Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage…
- Recall date
- July 17, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2770-2020
- FDA classification
- Class II
- Brand / firm
- Ortho Clinical Diagnostics
- Sold / distributed
- Worldwide distribution - US Nationwide distribution.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
Get recall alerts
Free email alert whenever Ortho Clinical Diagnostics has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Ortho Clinical Diagnostics