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FDAMarch 25, 2022device

VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

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

The hazard

Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750000302

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 FSH Reagent Pack- IVD 1931922 — Recall Details · AllClear