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 | Terminated |
| Reason | XXX |
| 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. |
| Quantity | 342 vials |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and United Arab Emirates. |
| Initiated | 2020-11-02 |
| Classified | 2020-12-04 |
| Terminated | 2021-12-20 |
| Recall number | Z-0539-2021 |
| 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-0539-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86719/
Alerts for CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.