Chromsystems Instruments & Chemicals GmbH

• LAS — Clinical Toxicology1 device

• Z-1336-2022 — MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level IClass II·Terminated·2022-05-19
• Z-1337-2022 — MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level IIClass II·Terminated·2022-05-19
• Z-0536-2021 — 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.Class II·Terminated·2020-11-02
• Z-0537-2021 — MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - 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.Class II·Terminated·2020-11-02
• Z-0538-2021 — MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - 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.Class II·Terminated·2020-11-02
• Z-0539-2021 — 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.Class II·Terminated·2020-11-02
• Z-0521-2021 — 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.Class II·Completed·2020-10-29
• Z-0523-2021 — MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.Class II·Completed·2020-10-29
• Z-0522-2021 — 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.Class II·Completed·2020-10-29

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K080459 — CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSCode LAS·2009-11-17