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FDAJuly 17, 2020device

VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.

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

The hazard

The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750033355

Recall history

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

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