Medical device recalls Moderate risk

Chromsystems Instruments & Chemicals GmbH recalls MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Recall date
May 19, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1336-2022
FDA classification
Class II
Brand / firm
Chromsystems Instruments & Chemicals GmbH
Sold / distributed
US: NY, OH, CT.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

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