Drug recall
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination…
FDA recall event 67897 · Class II · Alfa Wassermann, Inc.
Key facts
| Event ID | 67897 |
|---|---|
| Recall numbers | Z-1529-2014, Z-1530-2014 |
| Recalling firm | Alfa Wassermann, Inc. |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Extremely low absorbance readings. |
| Initiation date | Mar 5, 2014 |
| Report date | May 7, 2014 |
| Termination date | Aug 13, 2015 |
| City | West Caldwell |
| State | NJ |
| Country | United States |
| FEI number | 1000122044 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: