FDA Device recall Z-1337-2022
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
- 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 II 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-1337-2022 |
| 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 II
Reason
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Identifiers
| code_info | Model: 0193; Lot Number: 2821; UDI/DI: 04250317502865 |
|---|
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-1337-2022%22
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