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FDAJune 5, 2023device

VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

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

The hazard

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750002504

Recall history

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

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VITROS Immunodiagnostic Products Troponin I ES Reagent Pack — Recall Details · AllClear