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FDAJuly 30, 2020device

AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

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

The hazard

Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

UPCs

05022273200256

Recall history

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

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