FDA Device recall Z-0537-2021
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screenin…
- FDA Device
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screenin… by Chromsystems Instruments And Chemicals, citing products do not meet stability criteria and may impact results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0537-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-02 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Chromsystems Instruments And Chemicals |
| Distribution | US |
Product
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Reason
Products do not meet stability criteria and may impact results.
Identifiers
| code_info | Order No. 0471, Lot No. 2019 (expiration 05/01/2022) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0537-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.