MassChrom Amino Acid Analysis Plasma Control Level III — Class II medical device recall Z-0539-2021
Terminated recall by Chromsystems Instruments & Chemicals GmbH, reported 2020-12-16, distributed nationwide. XXX
| Recall number | Z-0539-2021 |
|---|---|
| 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 | 2020-11-02 |
| Classified | 2020-12-04 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2021-12-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, DE, FI, FR, GR, HR, IL, IT, KW, RU, TR, TW, ZA |
| Quantity | 342 vials |
| Lot numbers | 2019 |
| Expiration dates | 2022-05-01 |
Product
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Reason for recall
XXX
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-0539-2021. 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.