Recall Z-1336-2022— Chromsystems Instruments & Chemicals GmbH
Class II · Terminated
Class II FDA medical device recall by Chromsystems Instruments & Chemicals GmbH, initiated 2022-05-19, terminated 2024-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I. Reason: Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products..
- Recalling firm
- Chromsystems Instruments & Chemicals GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-05-19
- Terminated
- 2024-05-15
- Firm location
- Grafelfing, N/A, Germany
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.