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Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usa
Recalled August 19, 2020 · FDA recall Z-2771-2020 · Ortho Clinical Diagnostics
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. · FDA Class II
Units
2349 sales units
Sold at
Worldwide distribution - US Nationwide distribution.
Description
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.
Product
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.
Manufacturer(s)
Ortho Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →