FDAFebruary 20, 2019device

VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

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

The hazard

Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750000272

Recall history

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

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