Grafelfing, N/A, Germany
Chromsystems Instruments & Chemicals GmbH recalls
3 recalls recorded since 2018, most recently on 19 May 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 19 May 2022
- Terminated
- 15 May 2024
- Reason
- Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
- Distribution
- US: NY, OH, CT.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1336-2022, Z-1337-2022
- MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
- MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Terminated Class II Medical devices
- Recall started
- 2 November 2020
- Terminated
- 20 December 2021
- Reason
- Products do not meet stability criteria and may impact results.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0537-2021, Z-0536-2021, Z-0539-2021, Z-0538-2021
- 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 individu
- 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 diagnose
- 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 indivi
- 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 individ
Completed Class II Medical devices
- Recall started
- 29 October 2020
- Reason
- Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
- Distribution
- US Nationwide distribution in the states of NC and NY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0521-2021, Z-0523-2021, Z-0522-2021
- 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.
- 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.
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.