Chromsystems Instruments & Chemicals GmbH FDA Recalls

2 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level IClass IIMay 19, 2022Too low concentration of glycine was detected in the dried b	Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.	Class IIDevices	May 19, 2022
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level IIClass IIMay 19, 2022Too low concentration of glycine was detected in the dried b	Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.	Class IIDevices	May 19, 2022