FDA Device recall Z-1269-2014
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum
- FDA Device
- Class II
- terminated
- Published 2014-04-02
On 2014-04-02 the FDA classified a Class II recall of AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum by Ams Diagnostics, citing marketing the devices outside 510(k) requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1269-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-11 |
| Published | 2014-04-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ams Diagnostics |
| Distribution | US |
Product
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Reason
Marketing the devices outside 510(k) requirements
Identifiers
| code_info | Model Numbers: 40072, 40146, 80146. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811…Model Numbers: 40072, 40146, 80146. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1269-2014%22
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