MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
FDA Recall Z-1337-2022 · Posted None
Recalling FirmChromsystems Instruments & Chemicals GmbH
Recall StatusTerminated
Product CodeJJY
Date Initiated2022-05-19
Date Terminated2024-05-15
Product Quantity1457 units
Reason for Recall
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Firm Action
The firm issued a recall notification on 05/19/2022 via email. The notification mentions if the consignee has used the affected product, check whether they have determined glycine, replace the old package insert with the updated package insert with release date 18.05.2022, forward a copy of the letter to another laboratory if the affected product was given to them, and submit the response form by 01.06.2022. If users determined glycine, they are asked to clarify with the attending physician or laboratory director, if necessary,
whether a back-check of the values for glycine is required.
Root Cause
Labeling Change Control
Distribution Pattern
US: NY, OH, CT.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.