Device 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.
Z-2771-2020
Product summary
- Event
- Event 86038
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2349 sales units
- Official record key
device-enforcement:Z-2771-2020
Official wording
Reason: 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.
Code information: Lots 0010 - 0013
Distribution pattern: Worldwide distribution - US Nationwide distribution.
Derived failure modes
-
Unknown
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.