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FDAAugust 5, 2023device

VITROS XT Chemistry Products TBIL-ALKP Slides

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

The hazard

Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750031801

Recall history

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

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VITROS XT Chemistry Products TBIL-ALKP Slides — Recall Details · AllClear