Device recall
Z-1793-2014: APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233…
FDA device recall · Class III · Gen-Probe Inc
Key facts
| Recall number (Z-number) | Z-1793-2014 |
|---|---|
| Recall event | 68229 |
| Product | APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and… |
| Product code | OIE |
| Recalling firm | Gen-Probe Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 26, 2014 |
| 510(k) numbers | K003395 |
| FEI number | 2024800 |
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