Chromsystems Instruments & Chemicals GmbH
Chromsystems Instruments & Chemicals GmbH has 3 FDA enforcement events on this register (9 product records) between 2020 and 2022: 3 device; the busiest year was 2020 with 2.
0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in N/A.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 19 May 2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I | Device | Class II | 2 | Terminated |
| 2 Nov 2020 | 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. | Device | Class II | 4 | Terminated |
| 29 Oct 2020 | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels. | Device | Class II | 3 | Completed |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Chromsystems Instruments & Chemicals GmbH had?
3 enforcement events (9 product records) on this register, 2020–2022: 3 device.
Are any Chromsystems Instruments & Chemicals GmbH recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Chromsystems Instruments & Chemicals GmbH recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.