Medium RiskFDA Device

Chromsystems Instruments & Chemicals GmbH: Products do not meet stability criteria and may impact results.; XXX

Agency Publication Date: December 4, 2020

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Affected Products

Product: 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.

Order No. 75128, Lots No. 2219 (expiration 05/01/2022) and 2320 (expiration 06/01/2023)

Product: 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.

Order No. 0471, Lot No. 2019 (expiration 05/01/2022)

Product: 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.

Order No. 0472, Lot No. 2019 (expiration 05/01/2022)

Product: 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.

Order No. 0473, Lot No. 2019 (expiration 05/01/2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86719

Status: Resolved

Manufacturer: Chromsystems Instruments & Chemicals GmbH

Manufactured In: Germany

Units Affected: 4 products (200 packaging units; 362 vials; 363 vials; 342 vials)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.