Salt Lake City, UT, United States
BioFire Diagnostics, LLC recalls
34 recalls recorded since 2018, most recently on 12 August 2026. 21 are listed as ongoing. Status and classification are as published by the FDA.
Recalls34
Ongoing (FDA)21
Terminated or completed13
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 12 August 2026
- Reason
- Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Unite
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0150-2027, Z-0149-2027, Z-0148-2027
- Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-
- Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type res
- Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-AS
Ongoing Class II Medical devices
- Recall started
- 24 June 2026
- Reason
- Due to increase in false negative results
- Distribution
- U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2936-2026
- BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Ongoing Class II Medical devices
- Recall started
- 22 April 2026
- Reason
- Contamination to in-vitro diagnostic test may result in false positives.
- Distribution
- Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, Dominican Republic, Serbia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2067-2026
- BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Ongoing Class II Medical devices
- Recall started
- 1 April 2026
- Reason
- Respiratory/sore throat panel test may result in false negative results and control failures.
- Distribution
- US Nationwide distribution in the states of MS, TX MN, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2081-2026
- Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Ongoing Class II Medical devices
- Recall started
- 22 October 2025
- Reason
- Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
- Distribution
- US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0602-2026
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Ongoing Class II Medical devices
- Recall started
- 30 April 2025
- Reason
- Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
- Distribution
- International distribution in the country of Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1877-2025
- BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Ongoing Class II Medical devices
- Recall started
- 27 February 2025
- Reason
- Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
- Distribution
- OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1518-2025
- FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Ongoing Class II Medical devices
- Recall started
- 7 August 2024
- Reason
- Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.
- Distribution
- Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3122-2024, Z-3123-2024
- FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
- FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
Ongoing Class II Medical devices
- Recall started
- 19 June 2024
- Reason
- If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.
- Distribution
- Worldwide - US Nationwide distribution including in the states of FL, IL, KY, CO, KS, NC, AK, NY, ND, CA, TX, MD, GA, OH, WI, SD, LA, MT, VA, IA, MO, MA, WV, NE, OK, AZ, OR, SC, MI, IN, ID, TN, WA, NM, NJ, AR, AL, MN, NH, NV, PA, WY, MS, CT and the countries of AE, AM, AR, AT, BA, BG, BH, BN, BR, CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2456-2024
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
Ongoing Class II Medical devices
- Recall started
- 10 June 2024
- Reason
- Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
- Distribution
- Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2683-2024, Z-2682-2024
- BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
- BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Ongoing Class II Medical devices
- Recall started
- 16 May 2024
- Reason
- Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
- Distribution
- U.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY. O.U.S.: Worldwide - AR, AU, AT, BE, BR, CA,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2514-2024
- BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a
Ongoing Class II Medical devices
- Recall started
- 26 January 2024
- Reason
- Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, US Virgin Island, VT, WA, WI, WV, and W
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1140-2024
- FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.
Ongoing Class II Medical devices
- Recall started
- 26 January 2024
- Reason
- Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1139-2024
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Ae
Ongoing Class II Medical devices
- Recall started
- 14 December 2023
- Reason
- Their is a potential for false positive results when using Pneumonia panel.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Bolivia, Brazil,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0993-2024, Z-0994-2024
- FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
- FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Ongoing Class II Medical devices
- Recall started
- 27 November 2023
- Reason
- A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
- Distribution
- US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0704-2024, Z-0703-2024
- The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.
- BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Ongoing Class II Medical devices
- Recall started
- 17 October 2023
- Reason
- Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.
- Distribution
- Worldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA, WI, NC,, AK, PA, MN, ND, IN, AR, CO, UT, TX, AL, NJ, MD, SD, LA, OR, MA, ID, NE, MT, VA, IA, MO, WV, TN, MI, WY, SC, AZ, WA, NH, OK, HI, MS, DC, VT, CT, NM, RI, ME, NV; and OUS (foreign) to countries of: Algeria, Angola,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0451-2024
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for u
Ongoing Class II Medical devices
- Recall started
- 17 October 2023
- Reason
- Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, N, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and W
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0353-2024
- FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro dia
Ongoing Class II Medical devices
- Recall started
- 8 May 2023
- Reason
- Due to manufacturing issue, panels may result in false negative results.
- Distribution
- US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2439-2023, Z-2440-2023
- BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
- FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Ongoing Class II Medical devices
- Recall started
- 25 April 2023
- Reason
- The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
- Distribution
- US:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. OUS: AD, AE, AI, AR, AT, AU, BD, BE, BF, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2588-2023
- FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Ongoing Class II Medical devices
- Recall started
- 8 March 2023
- Reason
- Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
- Distribution
- US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1392-2023
- FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Ongoing Class II Medical devices
- Recall started
- 1 February 2023
- Reason
- Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
- Distribution
- U.S. Nationwide distribution in the states of FL and GA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1251-2023, Z-1252-2023, Z-1253-2023
- In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
- In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
- In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Terminated Class II Medical devices
- Recall started
- 11 October 2021
- Terminated
- 10 August 2023
- Reason
- Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. The Countries of Algeria, Argentin
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0312-2022
- BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerob
Terminated Class II Medical devices
- Recall started
- 20 July 2021
- Terminated
- 16 December 2022
- Reason
- Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
- Distribution
- U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2245-2021
- FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Terminated Class II Medical devices
- Recall started
- 7 June 2021
- Terminated
- 31 July 2023
- Reason
- Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
- Distribution
- U.S.: AK, AL, AZ, CA, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, IN, KS, KY, KY, LA, MA, MD, ME, MI, MI, MN, MO, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Algeria, Angola, Anguilla, Argentina, Australia, Aust
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2039-2021, Z-2040-2021
- FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
- FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
Terminated Class II Medical devices
- Recall started
- 10 May 2021
- Terminated
- 15 December 2022
- Reason
- Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
- Distribution
- US nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1903-2021
- BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Terminated Class II Medical devices
- Recall started
- 16 April 2021
- Terminated
- 2 April 2024
- Reason
- Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
- Distribution
- U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1944-2021
- FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Terminated Class II Medical devices
- Recall started
- 26 January 2021
- Terminated
- 2 May 2022
- Reason
- The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1157-2021, Z-1158-2021
- Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00
- BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
Terminated Class II Medical devices
- Recall started
- 22 January 2020
- Terminated
- 14 April 2021
- Reason
- There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austria, Australia, Azerbaijan, Belgium, Bosnia-Herz., Botswana, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Columbia, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Sa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2295-2020, Z-2296-2020
- FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plu
- FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus
Terminated Class II Medical devices
- Recall started
- 8 August 2019
- Terminated
- 12 April 2022
- Reason
- Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
- Distribution
- US: KY, IL, NJ, MS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1451-2020
- FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Terminated Class II Medical devices
- Recall started
- 7 March 2019
- Terminated
- 24 August 2022
- Reason
- Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
- Distribution
- MA, NH, VT, CT, NJ, NY, PA, DE, DC, VA, MD, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, WY, ID, UT, AZ, NM, NV, CA, HI, OR, WA, AK, BM
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1133-2019
- FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT
Terminated Class II Medical devices
- Recall started
- 6 March 2019
- Terminated
- 18 February 2022
- Reason
- Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: CO, IL, NJ, PA, OH, FL, KY, NE, NY, CA, WV, UT, TX, MS, OK, WI, NC, DE, IN, MN, AK, ND, GA, AR, MO, KS, HI, IA, LA, VA, SC, MT, NM, SD, AL, WY, AZ, WA, TN, OR, MI, MA, NV, MD, CT, DC, VT, ID, NH, RI, ME. Foreign (OUS): Argentina, Austria, A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1242-2019
- FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic a
Terminated Class II Medical devices
- Recall started
- 10 September 2018
- Terminated
- 28 April 2021
- Reason
- Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: CA DC, FL, IN, KY, MN, MO, NB, NJ, OH, TX and WI. International: Canada, Columbia and Mexico
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0446-2019
- -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) whi
Terminated Class II Medical devices
- Recall started
- 5 September 2018
- Terminated
- 22 March 2021
- Reason
- Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
- Distribution
- Worldwide distribution. US nationwide, Kuwait, Lebanon, Malaysia, Myanmar, Nicaragua, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Slovenia, Uruguay, United Arab Emirates, Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0296-2019
- FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used
Terminated Class II Medical devices
- Recall started
- 14 March 2018
- Terminated
- 24 October 2018
- Reason
- There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
- Distribution
- Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, G
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1513-2018
- FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 4
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.