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 | Completed |
| Reason | Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone. |
| Product | MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels. |
| Quantity | 880 vials |
| Distribution | US Nationwide distribution in the states of NC and NY. |
| Initiated | 2020-10-29 |
| Classified | 2020-12-02 |
| Recall number | Z-0522-2021 |
| 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-0522-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86699/
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