FDA Device recall Z-1529-2014
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT 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 ALT Reagent by Alfa Wassermann, citing extremely low absorbance readings.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1529-2014 |
| 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 ALT Reagent. Product Usage: For quantitative determination of ALT 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 labs.
Reason
Extremely low absorbance readings.
Identifiers
| code_info | ACE¿ ALT Reagent (Product reorder number SA1046 Lot F3604) |
|---|
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-1529-2014%22
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