Device product
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
Z-2256-2021
Product summary
- Event
- Event 88261
- Status
- Terminated
- Classification
- Class II
- Quantity
- 451 units
- Official record key
device-enforcement:Z-2256-2021
Official wording
Reason: SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Code information: All Lots
Distribution pattern: US Nationwide Distribution in the states of Alabama Alaska Arizona Arkansas California Connecticut Delaware Florida Georgia Idaho Illinois Indiana Iowa Kentucky Louisiana Maine Maryland Massachusetts Michigan Mississippi New Hampshire New Jersey New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Tennessee Texas Virginia West Virginia, Wisconsin OUS: New Zealand, Libya
Derived failure modes
-
Unknown
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .