Device product
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Z-1670-2021
Product summary
- Event
- Event 87738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,034 units
- Official record key
device-enforcement:Z-1670-2021
Official wording
Reason: specimens collected in transport media may result is false negative results when stored in certain conditions.
Code information: All Lots
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of Alabama, 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 and the country of New Zealand.
Derived failure modes
-
Unknown
specimens collected in transport media may result is false negative results when stored in certain conditions.