Z-1336-2022 Class II Terminated
FDA device recall Z-1336-2022 was initiated by Chromsystems Instruments & Chemicals GmbH on May 19, 2022 and is designated Class II. Reason for recall: Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. The recall status is terminated (terminated May 15, 2024). Affected quantity: 1330 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 13, 2022
- Initiation Date
- May 19, 2022
- Termination Date
- May 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1330 units
Product Description
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Reason for Recall
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Distribution Pattern
US: NY, OH, CT.
Code Information
Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841