Device product
PTS Panels CHOL+GLU Test Strips (REF 1765)
Z-1741-2022
Product summary
- Event
- Event 90791
- Status
- Completed
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1741-2022
Official wording
Reason: Incorrect instructions for use were packaged into the final product.
Code information: Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
Derived failure modes
-
Unknown
Incorrect instructions for use were packaged into the final product.