Z-1337-2022 Class II Terminated
FDA device recall Z-1337-2022 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: 1457 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
- 1457 units
Product Description
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
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: 0193; Lot Number: 2821; UDI/DI: 04250317502865