FDA recall Z-1336-2022
Chromsystems Instruments & Chemicals GmbH · Class II · device
Product
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
US: NY, OH, CT.
Key facts
- Status
- Terminated
- Initiation date
- 2022-05-19
- Report date
- 2022-07-13
- Termination date
- 2024-05-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Grafelfing, N/A, Germany
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1336-2022