Alfa Wassermann Diagnostic Technologies — Class II medical device recall Z-1529-2014
Terminated recall by Alfa Wassermann, Inc., reported 2014-05-07, distributed nationwide. Extremely low absorbance readings.
| Recall number | Z-1529-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alfa Wassermann, Inc., West Caldwell, NJ, United States |
| Recall initiated | 2014-03-05 |
| Classified | 2014-04-29 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2015-08-13 |
| Distributed | Nationwide (US) |
| Quantity | 731 kits |
| Lot numbers | F3604 |
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 for recall
Extremely low absorbance readings.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1529-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.