PlainRecalls
FDA Devices Moderate Class II Terminated

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Reported: July 13, 2022 Initiated: May 19, 2022 #Z-1336-2022

Product Description

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Reason for Recall

Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.

Details

Units Affected
1330 units
Distribution
US: NY, OH, CT.
Location
Grafelfing, N/A

Frequently Asked Questions

What product was recalled?
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I. Recalled by Chromsystems Instruments & Chemicals GmbH. Units affected: 1330 units.
Why was this product recalled?
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 13, 2022. Severity: Moderate. Recall number: Z-1336-2022.