The Recall Desk

Manufacturer

Radiometer Medical ApS

25 recalls in our database name Radiometer Medical ApS as the manufacturing or recalling firm.

What the numbers show

Total
25
Critical
0
Severe
2
Most recent
2025-04-30

Of the 25 recalls from Radiometer Medical ApS we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 25

  • ModerateFDA (Devices)·Z-1659-2025·2025-04-30

    Radiometer ABL90 Series Blood Analyzers May Unexpectedly Freeze

    Radiometer ABL90 FLEX and ABL90 FLEX PLUS analyzers running Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may freeze unexpectedly during sample measurement, causing test results to be lost and delayed.

    Product
    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 in the laboratory environment, near patients or point-of-care
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2426-2024·2024-07-31

    ABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results

    Radiometer Medical ABL800 FLEX blood gas analyzers (models 393-800, 393-801) may report inaccurate pH results due to bacterial growth in calibration solution bottles. Approximately 27,127 units distributed worldwide are affected.

    Product
    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, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglob
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1394-2023·2023-04-26

    Radiometer AQURE Software Recall Due to Patient Mix-up Risk

    Radiometer is recalling AQURE laboratory software versions 2.5.2 through 2.6.1 due to a potential issue that could cause patient data mix-ups.

    Product
    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 system shows test results. The system receives data from co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1321-2022·2022-07-13

    ABL800 Flex Analyzer Recalled for Potential Measurement Bias

    Radiometer Medical is recalling ABL800 Flex Analyzers that may produce biased measurements in sodium, calcium, and potassium levels. Approximately 1,489 analyzers are affected worldwide.

    Product
    ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1115-2022·2022-05-25

    Radiometer Arterial Blood Sampler recalled due to sterility guarantee loss

    Radiometer Medical is recalling Arterial Blood Samplers (REF:956-552) because sterility cannot be guaranteed throughout the product's shelf life. The recall affects 7,228 boxes distributed worldwide.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2021·2021-06-23

    Medical Device Analyzer Spare Parts Recalled for Internal Clock Defect

    Radiometer Medical ApS recalls E3800 PC Units spare parts due to an internal clock defect affecting analyzers. Approximately 965 units have been distributed worldwide, with 35 in the United States.

    Product
    E3800 PC Units (spare parts)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1856-2021·2021-06-23

    Radiometer ABL90 FLEX Analyzer Recalled Due to Internal Clock Malfunction

    Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with E3800 PC units due to an internal clock issue. Approximately 3,346 units are affected globally, with only 2 in the United States.

    Product
    Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2021·2021-06-23

    Radiometer ABL90 FLEX PLUS Analyzer Recalled Due to Internal Clock Issue

    Radiometer is recalling ABL90 FLEX PLUS Analyzers with E3800 PC units due to an internal clock issue. Approximately 4,135 units are affected worldwide, including 1,277 in the United States.

    Product
    Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2021·2021-06-02

    Radiometer Recalls PICO70 Arterial Blood Samplers Due to Sterile Barrier Breach

    Radiometer is recalling PICO70 Arterial Blood Samplers because a sterile barrier breach was found during testing, posing a risk of bacterial infection.

    Product
    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 analysis. Model Number/Product Description: 956-518 PICO7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2020·2020-07-15

    Radiometer ABL800 FLEX Blood Gas Analyzer Software Recall

    Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that may cause patient mix-ups.

    Product
    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 configurations.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2493-2020·2020-07-15

    Radiometer ABL800 FLEX Blood Gas Analyzers Recalled for Software Issues

    Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that creates a potential risk of patient mix-up.

    Product
    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, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Bas
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2468-2020·2020-07-08

    Radiometer ABL80-FLEX CO-OX Box Label Recall for Barcode Misinterpretation

    Radiometer Medical ApS is recalling ABL80-FLEX CO-OX box labels because barcode misinterpretation on analyzers may cause patient mix-ups or delayed treatment.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2020·2020-07-08

    Radiometer ABL80-FLEX Box Label Recall for Barcode Misinterpretation Risk

    Radiometer Medical ApS is recalling ABL80-FLEX box labels because barcode misinterpretation on analyzers may cause patient mix-ups or delayed treatment.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2248-2020·2020-06-10

    Radiometer safeCLINITUBES Blood Samplers Recalled for Insufficient Aspiration

    Radiometer Medical ApS is recalling safeCLINITUBES Blood Samplers because they may have insufficient aspiration capabilities, potentially resulting in lost samples.

    Product
    safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-2138-2020·2020-06-03

    Radiometer ABL90 FLEX Plus Analyzers Recalled for Measurement Errors

    Radiometer Medical ApS is recalling ABL90 FLEX Plus analyzers and hemolyzer units because defective cuvettes cause inaccurate blood measurements.

    Product
    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 laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2020·2020-06-03

    Radiometer ABL90 FLEX Analyzers Recalled for Hemolyzer Measurement Errors

    Radiometer Medical ApS is recalling ABL90 FLEX analyzers and spare hemolyzer units because defective cuvettes cause light shunts, leading to inaccurate measurement results.

    Product
    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 laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1836-2020·2020-05-06

    Radiometer ABL800 FLEX Blood Gas Analyzer Recall for Power Supply Defect

    Radiometer Medical ApS is recalling two ABL800 FLEX analyzers in California due to a power supply defect that may cause treatment delays and serious health risks.

    Product
    ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1755-2020·2020-04-29

    Radiometer TCM4 Base Unit Recalled for Display Flickering and Unresponsiveness

    Radiometer Medical ApS is recalling 84 TCM4 Base units due to reports of display flickering and unresponsiveness, which may delay patient monitoring.

    Product
    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 indicated for use on pediatrics and adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2020·2020-04-29

    Radiometer ABL90 FLEX Analyzer Recalled for Barcode Reader Error

    Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with software below 3.4MR2 because the barcode reader may misinterpret labels, risking patient mixups and delayed treatment.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1761-2020·2020-04-29

    Radiometer ABL90 FLEX PLUS Analyzer Recalled Due to Barcode Misinterpretation

    Radiometer Medical ApS is recalling ABL90 FLEX PLUS Analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or lost samples.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2020·2020-04-15

    Radiometer ABL800 FLEX Blood Gas Analyzer Barcode Reader Recall

    Radiometer Medical ApS is recalling ABL800 FLEX analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or sample loss.

    Product
    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 hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0864-2020·2020-02-05

    Radiometer AQURE basic system software recall for patient data mix-up risk

    Radiometer Medical ApS is recalling AQURE basic system software versions 2.3.5 and below due to a potential patient data mix-up risk when connected to third-party devices.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2018·2018-05-09

    Radiometer AQURE Software Recalled for Potential Patient Data Mix-Up

    Radiometer Medical ApS is recalling AQURE software versions 2.3.0 and 2.3.1 due to a potential problem that may result in patient mix-up.

    Product
    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 system shows test results. The system receives data from connec
    Category
    Medical Device
    Distribution
    Distributed nationwide