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Chromsystems Instruments & Chemicals Recalls
9 recalls on record · December 9, 2020 to July 13, 2022 · Medical Devices
Recalls by year
20
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 13, 2022Medical DevicesFDA
Chromsystems Instruments & Chemicals GmbH recalls MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Hazard: Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
July 13, 2022Medical DevicesFDA
Chromsystems Instruments & Chemicals GmbH recalls MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Hazard: Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
December 16, 2020Medical DevicesFDA
Chromsystems Instruments & Chemicals GmbH recalls MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino ac
Hazard: XXX
December 16, 2020Medical DevicesFDA
Chromsystems Instruments & Chemicals GmbH recalls MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino aci
Hazard: XXX
December 16, 2020Medical DevicesFDA
Chromsystems Instruments & Chemicals GmbH recalls MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid
Hazard: Products do not meet stability criteria and may impact results.
December 16, 2020Medical DevicesFDA
Chromsystems Instruments & Chemicals GmbH recalls 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic s
Hazard: Products do not meet stability criteria and may impact results.
December 9, 2020Medical DevicesFDA
Chromsystems Instruments & Chemicals GmbH recalls MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for pat
Hazard: Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
December 9, 2020Medical DevicesFDA
Chromsystems Instruments & Chemicals GmbH recalls MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for pati
Hazard: Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
December 9, 2020Medical DevicesFDA
Chromsystems Instruments & Chemicals GmbH recalls 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used a
Hazard: Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.