FDA recall Z-1337-2022
Chromsystems Instruments & Chemicals GmbH · Class II · device
Product
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
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-1337-2022