Device product
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Z-2382-2021
Product summary
- Event
- Event 88478
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 kits
- Official record key
device-enforcement:Z-2382-2021
Official wording
Reason: The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Code information: Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.
Distribution pattern: US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
Derived failure modes
-
Unknown
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128