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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Radiometer Medical ApS: Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Agency Publication Date: June 15, 2021
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Affected Products

Product: Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Model Number: ABL90 FLEX (393-090) Serial Numbers: ABL90 FLEX analyzers with serial number R0996 R1000, and R1003 onwards

Product: Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Model Number: ABL90 FLEX PLUS (393-092) Serial Numbers: ABL90 FLEX PLUS analyzers serial numbers R0214 R0218, and R0223 onwards

Product: E3800 PC Units (spare parts)

Part number: 910-414

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87870
Status: Active
Manufacturer: Radiometer Medical ApS
Manufactured In: Denmark
Units Affected: 3 products (Total=3,346 analyzers world-wide (only 2 analyzers within the U.S.); Total=4,135 analyzers world-wide (only 1277 analyzers within the U.S.); Total 965 PC units World-wide (only 35 units in the U.S.))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.