Device recall
Z-0217-05: IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2…
FDA device recall · Class III · Abbott Health Products, Inc.
Key facts
| Recall number (Z-number) | Z-0217-05 |
|---|---|
| Recall event | 30388 |
| Product | IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV… |
| Product code | LOL |
| Recalling firm | Abbott Health Products, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 16, 2005 |
| PMA numbers | P780012, P780012S007 |
| FEI number | 2623532 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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