MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Recall
- Recall Number
- Z-1336-2022
- Event Number
- 90266
- Firm
- Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany
- FEI Number
- 3003951180
- Product Code
- JJY
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- May 19, 2022
- Terminated
- May 15, 2024
Description
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
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.
US: NY, OH, CT.
1330 units