FDA Device

ABL800 Flex Analyzer Model Numbers 393-800 and 393-801

Hazard

There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.

What You Should Do

Remedy

On May 20, 2022, Radiometer issued a "Urgent: Medical Device Recall" notification to affected consignees via: Email and FedEx 2nd day Mail. Radiometer ask consignees to take the following actions: 1. For the affected micro measuring modes Radiometer kindly requests you to not use results for cNa+. The most efficient way to ensure this is to remove the parameter from the affected modes as per the procedures included within the letter. 2. Please complete the Recall Response Form and return to your Radiometer representative (recall@radiometeramerica.com).

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Products

ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Brand
Radiometer Medical ApS Akandevej 21 Bronshoj Denmark
UPC
All ABL800 Flex Analyzers containing software versions below V6.19 MR2; UDI/DI ABL810, 820, and 830, ABL805, ABL815, ABL825, ABL835: 05700693938004 ; UDI/DI ABL817, ABL827, ABL837: 05700693938011

Units Affected

1489 analyzers

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