Device product
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Z-1336-2022
Product summary
- Event
- Event 90266
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1330 units
- Official record key
device-enforcement:Z-1336-2022
Official wording
Reason: Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Code information: Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841
Distribution pattern: US: NY, OH, CT.
Derived failure modes
-
Unknown
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.