MassCheck Amino Acid — Class II medical device recall Z-1336-2022
Terminated recall by Chromsystems Instruments & Chemicals GmbH, reported 2022-07-13, distributed in CT, NY, OH. Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
| Recall number | Z-1336-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Chromsystems Instruments & Chemicals GmbH, Grafelfing, N/A, Germany |
| Recall initiated | 2022-05-19 |
| Classified | 2022-07-06 |
| Reported by FDA | 2022-07-13 |
| Terminated | 2024-05-15 |
| Distributed | CT, NY, OH |
| Quantity | 1,330 units |
| UPC / GTIN / UDI-DI | 04250317502841 |
| Lot numbers | 2821 |
| Model numbers | 0192 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1336-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.