Device recall
Z-0835-06: EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin…
FDA device recall · Class III · Thera Test Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0835-06 |
|---|---|
| Recall event | 34945 |
| Product | EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148 |
| Product code | MID |
| Recalling firm | Thera Test Laboratories, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 3, 2006 |
| 510(k) numbers | K060176 |
| FEI number | 1421346 |
At a glance
- 1–9 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