Germantown, MD, United States
Qiagen Sciences LLC recalls
19 recalls recorded since 2018, most recently on 12 March 2025. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls19
Ongoing (FDA)8
Terminated or completed11
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 12 March 2025
- Reason
- Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
- Distribution
- US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1504-2025
- Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Ongoing Class II Medical devices
- Recall started
- 3 June 2024
- Reason
- Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.
- Distribution
- Nationwide. Foreign: AD, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, ID, IN, IT, JO, KR, KZ, LU, ML, MY, NL, NO, PH, PL, PY, SA, SE, SG, SK, SO, VN J, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2353-2024
- QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Versio
Ongoing Class II Medical devices
- Recall started
- 4 March 2024
- Reason
- Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
- Distribution
- Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1508-2024
- EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230
Ongoing Class II Medical devices
- Recall started
- 28 April 2023
- Reason
- Faulty cartridges in the lot could result in false test results.
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1683-2023
- QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Ongoing Class II Medical devices
- Recall started
- 20 July 2022
- Reason
- Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects
- Distribution
- IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1652-2022, Z-1651-2022, Z-1650-2022
- FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
- therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
- therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Ongoing Class II Medical devices
- Recall started
- 25 February 2022
- Reason
- False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
- Distribution
- AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0951-2022, Z-0952-2022
- therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
- therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Ongoing Class II Medical devices
- Recall started
- 21 November 2021
- Reason
- During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
- Distribution
- Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1746-2022
- QIAcube Connect MDx, Model No. 9003070
Terminated Class II Medical devices
- Recall started
- 8 November 2021
- Terminated
- 29 March 2023
- Reason
- The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
- Distribution
- Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0455-2022
- QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Terminated Class II Medical devices
- Recall started
- 15 January 2021
- Terminated
- 11 July 2022
- Reason
- QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
- Distribution
- Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0941-2021
Terminated Class II Medical devices
- Recall started
- 11 December 2020
- Terminated
- 22 April 2022
- Reason
- Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
- Distribution
- CA, IN, MI, MN, NC, NJ, NM, OH, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0937-2021
- therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
Terminated Class II Medical devices
- Recall started
- 15 July 2020
- Terminated
- 22 March 2021
- Reason
- There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.
- Distribution
- US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY, OH, OR, PA, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2938-2020
- QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organism
Terminated Class II Medical devices
- Recall started
- 8 April 2020
- Terminated
- 3 June 2021
- Reason
- There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2290-2020
- therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Terminated Class II Medical devices
- Recall started
- 21 February 2020
- Terminated
- 5 October 2020
- Reason
- An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
- Distribution
- Nationwide domestic distribution. Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1636-2020
- AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)
Terminated Class II Medical devices
- Recall started
- 28 January 2020
- Terminated
- 26 September 2024
- Reason
- When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false negative result, which could lead to serious medical consequences such as the suspension or non-initiation of treatment
- Distribution
- Worldwide distribution - US Nationwide distribution and countries Afghanistan, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cameroon, Canada, Chile, China, Colombia, Congo, Costa Ric
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1476-2020
- QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
Ongoing Class II Medical devices
- Recall started
- 2 July 2019
- Reason
- QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream application the incorrect tube may be selected and it could have the potential to lead to delayed results or incorrect patient reporting
- Distribution
- Worldwide Distribution - US Nationwide Foreign: Algeria Australia Austria Azerbaijan Belgium Brazil Canada China Czech Republic Denmark Finland France Germany Greece India Israel Italy Japan Jordan Korea, Republic of Kuwait Latvia Mexico Netherlands Norway Pakistan Poland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2319-2019
- QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The
Terminated Class I Medical devices
- Recall started
- 5 June 2019
- Terminated
- 28 August 2020
- Reason
- Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)
- Distribution
- US Nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2088-2019
- Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation
Terminated Class II Medical devices
- Recall started
- 6 May 2019
- Terminated
- 23 April 2020
- Reason
- The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected lot, resulting in significantly reduced yields and less sensitive downstream applications.
- Distribution
- US nationwide distribution in the states of MA, RI, AZ, NY, NC, IN, TX. The products were distributed to the following foreign countries: Germany, Great Britain, Italy, France, Sweden, and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1891-2019
- RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be use
Terminated Class II Medical devices
- Recall started
- 23 July 2018
- Terminated
- 5 June 2020
- Reason
- An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extractions need to be repeated. This could cause a delay in obtaining results from downstream applications.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, GA, IA, ID, IL, MA, MD, MI, MN, NE, NJ, NY, NV, OH, PA, PR, SD, VA, and WA. The products were distributed to the following foreign countries: Alger, Argentina, Australia, Austria, Canada, China, Dubai, Egypt, France, Germany,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0383-2019
- EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combinat
Terminated Class I Medical devices
- Recall started
- 18 May 2018
- Terminated
- 2 September 2020
- Reason
- Potential for control line not appearing on the test strip
- Distribution
- Worldwide - US Nationwide distribution an in the country of , Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2577-2018
- AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection o
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.