MassChrom Cortisol — Class II medical device recall Z-0523-2021
Completed recall by Chromsystems Instruments & Chemicals GmbH, reported 2020-12-09, distributed nationwide. Control lots may not meet stability criteria and could result in increased results of patient samples for cort
| Recall number | Z-0523-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Chromsystems Instruments & Chemicals GmbH, Grafelfing, N/A, Germany |
| Recall initiated | 2020-10-29 |
| Classified | 2020-12-02 |
| Reported by FDA | 2020-12-09 |
| Distributed | Nationwide (US) |
| Quantity | 850 vials |
| Reason classes | specification failure |
| Lot numbers | 1020, 3219 |
| Expiration dates | 2021-08-01, 2022-03-01 |
Product
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Reason for recall
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
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-0523-2021. 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.