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FDAMay 18, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

radiometer medical apsradiometerradiometer medical

UPCs

0570069393800405700693938011

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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