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FDAJuly 3, 2024device

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

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

The hazard

It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

Recall history

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

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VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 — Recall Details · AllClear