Recall Z-1337-2022 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Chromsystems Instruments & Chemicals GmbH
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
| Date | May 19, 2022 |
| Status | Terminated |
| Reason | Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. |
| Root cause | Labeling Change Control |
| 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. |
| Quantity | 1457 units |
| Distribution | US: NY, OH, CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.