FDA-Device2022-07-13Class II
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Chromsystems Instruments & Chemicals GmbH
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-1337-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief