medical Class II Updated 2020-08-19

Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T.

Recalled Product

VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots 0010-0037
View official government recall

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