Chromsystems Instruments & Chemicals GmbH
FDA Regulatory Profile
Chromsystems Instruments & Chemicals GmbH appears in FDA public data with 9 recalls, 1 510(k) clearance, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1337-2022, Class II) was initiated on May 19, 2022. Its most recent 510(k) clearance was granted on Nov 17, 2009.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1337-2022 | Class II | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II | May 19, 2022 |
| Z-1336-2022 | Class II | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I | May 19, 2022 |
| Z-0538-2021 | Class II | MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is in | Nov 2, 2020 |
| Z-0537-2021 | Class II | MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is int | Nov 2, 2020 |
| Z-0536-2021 | Class II | 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for am | Nov 2, 2020 |
| Z-0539-2021 | Class II | MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is i | Nov 2, 2020 |
| Z-0522-2021 | Class II | MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is use | Oct 29, 2020 |
| Z-0521-2021 | Class II | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usag | Oct 29, 2020 |
| Z-0523-2021 | Class II | MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is us | Oct 29, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K080459 | CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS | Nov 17, 2009 |