Recall Z-1336-2022
Chromsystems Instruments & Chemicals GmbH · initiated May 19, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Codes / lots: Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841
Reason for recall
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-1336-2022
- Initiated
- May 19, 2022
- Terminated
- May 15, 2024
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 1330 units
- Distribution
- US: NY, OH, CT.
- Recalling firm
- Chromsystems Instruments & Chemicals GmbH, Grafelfing
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1337-2022 Class II | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level IIToo low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. | 05/19/2022Terminated |