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FDAOctober 11, 2024device

VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

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

The hazard

May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750000296

Recall history

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

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