Device recall
Z-0837-2012: SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set…
FDA device recall · Class III · Quest International, Inc.
Key facts
| Recall number (Z-number) | Z-0837-2012 |
|---|---|
| Recall event | 58551 |
| Product | SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1 Positive Control*, 1 Substrate, 1 Stop Solution, 1 Conjugate*, 1 Calibrator 1*, 1 Calibrator 2*, 1… |
| Product code | LKQ |
| Recalling firm | Quest International, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 31, 2012 |
| 510(k) numbers | K982485 |
| FEI number | 3000206132 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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