3PLUS1 Multilevel Plasma Calibrator Set — Class II medical device recall Z-0536-2021
Terminated recall by Chromsystems Instruments & Chemicals GmbH, reported 2020-12-16, distributed nationwide. Products do not meet stability criteria and may impact results.
| Recall number | Z-0536-2021 |
|---|---|
| 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 | 200 packaging |
| Reason classes | specification failure |
| Lot numbers | 2219 |
| Expiration dates | 2022-05-01, 2023-06-01 |
Product
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - 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
Products do not meet stability criteria and may impact results.
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-0536-2021. 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.