Device product
ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
Z-1361-2019
Product summary
- Event
- Event 82590
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1361-2019
Official wording
Reason: Devices were delivered without the required dry ice.
Code information: LN 09P3501; Lot 84347UN18
Distribution pattern: Distribution to Latvia.
Derived failure modes
-
Unknown
Devices were delivered without the required dry ice.