FDA Device recall Z-1530-2014
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent
- FDA Device
- Class II
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class II recall of Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent by Alfa Wassermann, citing extremely low absorbance readings.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1530-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-05 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alfa Wassermann |
| Distribution | US |
Product
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.
Reason
Extremely low absorbance readings.
Identifiers
| code_info | ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610) |
|---|
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-1530-2014%22
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