FDAClass IIJuly 13, 2022

MassCheck Amino Acid recall

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Why was MassCheck Amino Acid recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841

Product
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Recalling firm
Chromsystems Instruments & Chemicals GmbH
Quantity
1330 units
Distribution
US: NY, OH, CT.
Recall date
July 13, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
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