Device recall
Z-0482-2009: ACE and ACE Alera Hemoglobin A1C: EZA1C Reagent, EZA1C Controls, and EZA1C…
FDA device recall · Class II · Alfa Wassermann, Inc.
Key facts
| Recall number (Z-number) | Z-0482-2009 |
|---|---|
| Recall event | 49563 |
| Product | ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitro diagnostic use only. Alfa Wassermann Diagnostic Technologies, LLC., 4 Henderson Drive, West… |
| Product code | LCP |
| Recalling firm | Alfa Wassermann, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2009 |
| 510(k) numbers | K070734 |
| FEI number | 1000122044 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database