12 results
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76ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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.
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·December 16, 2020
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.
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·December 16, 2020
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·July 13, 2022
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.
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·December 16, 2020
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.
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·December 16, 2020
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·July 13, 2022
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.
FDA Recall
Terminated
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·November 2, 2020
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.
FDA Recall
Terminated
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·November 2, 2020
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.
FDA Recall
Terminated
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·November 2, 2020
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
FDA Recall
Terminated
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·May 19, 2022
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.
FDA Recall
Terminated
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JIX·November 2, 2020
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
FDA Recall
Terminated
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·May 19, 2022