Chromsystems Instruments & Chemicals GmbH
Medical device manufacturer in Grafelfing, Germ.
1510(k) clearances
0PMA approvals
9recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K080459 | Chromesytems Toxicology Calibrators and ControlsLAS · Abbreviated | 11/17/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1337-2022 Class II | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level IIToo low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. | 05/19/2022Terminated |
| Z-1336-2022 Class II | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level IToo low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. | 05/19/2022Terminated |
| Z-0539-2021 Class II | MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage:…XXX | 11/02/2020Terminated |
| Z-0538-2021 Class II | MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage:…XXX | 11/02/2020Terminated |
| Z-0537-2021 Class II | MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage:…Products do not meet stability criteria and may impact results. | 11/02/2020Terminated |
| Z-0536-2021 Class II | 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is…Products do not meet stability criteria and may impact results. | 11/02/2020Terminated |
| Z-0523-2021 Class II | MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage:…Control lots may not meet stability criteria and could result in increased results of patient samples for… | 10/29/2020Completed |
| Z-0522-2021 Class II | MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage:…Control lots may not meet stability criteria and could result in increased results of patient samples for… | 10/29/2020Completed |
| Z-0521-2021 Class II | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 -…Calibrator lots may not meet stability criteria and could result in increased results of patient samples for… | 10/29/2020Completed |