FDA-Device2022-07-13Class II

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

Hazard

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

Sold states
US: NY, OH, CT.
Affected count
1457 units
Manufactured in
Am Haag 12, N/A, Grafelfing, N/A, Germany
Products
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1337-2022

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