medical Class II Updated 2020-12-16

Chromsystems Instruments & Chemicals GmbH recalls 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - P

Recalled 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.

Hazard / Issue

Products do not meet stability criteria and may impact results.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Order No. 75128, Lots No. 2219 (expiration 05/01/2022) and 2320 (expiration 06/01/2023)
View official government recall

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