Bronshoj, N/A, Denmark
Radiometer Medical ApS recalls
18 recalls recorded since 2018, most recently on 18 August 2026. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls18
Ongoing (FDA)8
Terminated or completed10
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 August 2026
- Reason
- In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.
- Distribution
- US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY, CO, IL, TX, GA, NC, PA, SC, MI, OK, WI, AR, MN, OR, UT, WA, SD, IN, TN, AZ, NE, WY, KY, AL, AK, ID, NJ, DE, MT, CT, MS, MO, VT, WV, IA, MD, KS, DC, NV, VA, NM, NH, ND, ME, HI, RI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0190-2027
- The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. Th
Ongoing Class II Medical devices
- Recall started
- 21 March 2025
- Reason
- ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.
- Distribution
- U.S.: AL, AR, AZ, BM 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, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Canada, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1659-2025
- Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use i
Ongoing Class II Medical devices
- Recall started
- 31 May 2024
- Reason
- Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Canada, Afghanistan, Albania, Alger
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2426-2024
- ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ct
Ongoing Class II Medical devices
- Recall started
- 8 March 2023
- Reason
- Due to potential software issue that may result in patient mix-up information.
- Distribution
- Worldwide - U.S. Nationwide including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Brazil, Chile, China, Cr
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1394-2023
- AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The
Ongoing Class II Medical devices
- Recall started
- 18 May 2022
- Reason
- There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of 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, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Bermuda, Canada, Italy, Norwa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1321-2022
- ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Ongoing Class II Medical devices
- Recall started
- 8 April 2022
- Reason
- Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DC, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, TN, TX, WA, WI and the countries of Canada, Italy, Norway, Austria, Algeria, Argentina, Bolivia, Bosnia, Brazil, Burkina, Faso, Chile
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1115-2022
- Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
Ongoing Class II Medical devices
- Recall started
- 14 April 2021
- Reason
- Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, 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, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Italy, Norway, Austr
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1858-2021, Z-1856-2021, Z-1857-2021
- E3800 PC Units (spare parts)
- Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
- Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Terminated Class II Medical devices
- Recall started
- 26 March 2021
- Terminated
- 1 March 2023
- Reason
- Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection. The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock. Immunosuppressed patients are at particular risk. Due to issues (breaches) with the sterile barrier system for the Arterial Blood Sampler.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of CA, CO, FL, IL, LA, MA, MI, MO, MT, NJ, NY, OK, PA, TX, WA, and WI. The countries of Australia, New Zealand, Canada, Algeria, Bahrain, Belarus, Bosnia and Herzegovina, Colombia, Costa Rica, Ethiopia, Greece, Guatemala, Indonesia,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1683-2021
- PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite a
Terminated Class II Medical devices
- Recall started
- 26 May 2020
- Terminated
- 8 February 2023
- Reason
- Potential risk of patient mix-up on analyzers due to software issues.
- Distribution
- US - AL, AR, AZ, BM, 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, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. OUS - Australia, Austria, Canada, Czech Republic, China, Croatia, Denmark, France, Finland, Germany, Hu
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2493-2020, Z-2494-2020
- Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL
- Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configura
Terminated Class II Medical devices
- Recall started
- 11 May 2020
- Terminated
- 24 February 2023
- Reason
- Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AK, 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, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of CA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2468-2020, Z-2467-2020
- ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
- ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Terminated Class II Medical devices
- Recall started
- 17 March 2020
- Terminated
- 28 July 2022
- Reason
- The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
- Distribution
- U.S.: AK, AL, AR, CA, CO, CT, FL,GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and WI. OUS: Australia (New Zealand), Austria, Brazil Canada, China, Czech Republic (Slovakia), Denmark, Dubai (United Arab Emirates), Egypt,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2248-2020, Z-2249-2020, Z-2247-2020
- safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
- safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
- safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
Terminated Class II Medical devices
- Recall started
- 10 March 2020
- Terminated
- 31 October 2022
- Reason
- Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, BM, 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, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and countries of Canada, China, Czech Republ
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1684-2020
- ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the he
Ongoing Class II Medical devices
- Recall started
- 6 March 2020
- Reason
- Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
- Distribution
- US: in the state of California
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1836-2020
- ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Terminated Class II Medical devices
- Recall started
- 20 February 2020
- Terminated
- 24 June 2022
- Reason
- Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance.
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of FL, KS, NY, ND, IN, TX, CA , VA, MA, MN, WI, IN, CT, WA and the countries of China, India, Japan, south Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1755-2020
- TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indica
Terminated Class II Medical devices
- Recall started
- 3 February 2020
- Terminated
- 20 September 2022
- Reason
- The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of AK, 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, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1761-2020, Z-1760-2020
- ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
- ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Terminated Class II Medical devices
- Recall started
- 21 November 2019
- Terminated
- 8 November 2024
- Reason
- The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.
- Distribution
- Worldwide distribution - US Nationwide. Also distributed OUS.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2139-2020, Z-2138-2020
- ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a labor
- ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a la
Terminated Class II Medical devices
- Recall started
- 8 August 2019
- Terminated
- 6 June 2022
- Reason
- The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV; and countries of: Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0864-2020
- AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
Terminated Class II Medical devices
- Recall started
- 27 February 2018
- Terminated
- 20 March 2019
- Reason
- There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
- Distribution
- US Nationwide Distribution in the states to Georgia and Wisconsin.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1582-2018
- AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The sys
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.