RegWardenFDA facility compliance records
Facility

RADIOMETER BASEL AG

17 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2016: 1 inspections; 2018: 1 recalls; 2019: 2 recalls; 2020: 7 recalls; 2021: 2 recalls; 2022: 2 recalls; 2023: 1 recalls; 2024: 1 recalls; 2025: 1 recalls12016201712018220197202022021220221202312024120252026
  • Recalls (17)
  • Inspections (1)

Devices registered here (5)

  • Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
    Product code KLK (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.2500
  • Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
    Product code LPP (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.2500
  • Oximeter
    Product code DQA (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2700
  • Oximeter, Ear
    Product code DPZ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2710
  • Monitor, Carbon-Dioxide, Cutaneous
    Product code LKD (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.2480

Recalls & enforcement

20251 record
  • Class IIOngoing2025-03-21
    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 autom…
20241 record
  • Class IIOngoing2024-05-31
    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.
20231 record
20222 records
  • Class IIOngoing2022-05-18
    There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
  • Class IIOngoing2022-04-08
    Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
20212 records
  • Class IIOngoing2021-04-14
    Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
  • Class IITerminated2021-03-26
    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 fo…
20207 records
  • Class IITerminated2020-05-26
    Potential risk of patient mix-up on analyzers due to software issues.
  • Class IITerminated2020-05-11
    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 barco…
  • Class IITerminated2020-03-17
    The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
  • Class IITerminated2020-03-10
    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
  • Class IIOngoing2020-03-06
    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 cyanosi…
  • Class IITerminated2020-02-20
    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.
  • Class IITerminated2020-02-03
    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…
20192 records
  • Class IITerminated2019-11-21
    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 …
  • Class IITerminated2019-08-08
    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…
20181 record
  • Class IITerminated2018-02-27
    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.

FDA inspections (1)

  • NAI2016-10-20
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “RADIOMETER BASEL AG (FEI 3002663379) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002663379-radiometer-basel-ag/

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