Class II — Chromsystems Instruments & Chemicals GmbH
| Recalling firm | CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH |
|---|---|
| Registered facility | CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. |
| Product | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II |
| Quantity | 1457 units |
| Distribution | US: NY, OH, CT. |
| Initiated | 2022-05-19 |
| Classified | 2022-07-06 |
| Terminated | 2024-05-15 |
| Recall number | Z-1337-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Chromsystems Instruments & Chemicals GmbH (Z-1337-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90266/
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