FDA Device recall Z-1336-2022
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
- FDA Device
- Class II
- terminated
- Published 2022-07-13
On 2022-07-13 the FDA classified a Class II recall of MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I by Chromsystems Instruments And Chemicals, citing too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1336-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-19 |
| Published | 2022-07-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Chromsystems Instruments And Chemicals |
| Distribution | CT, NY, OH |
Product
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Reason
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Identifiers
| code_info | Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1336-2022%22
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