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Terminated

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

FDA Recall Z-1336-2022 · Posted None

Recall StatusTerminated
Product CodeJJY
Date Initiated2022-05-19
Date Terminated2024-05-15
Product Quantity1330 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.

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