Drug recall
APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The…
FDA recall event 68229 · Class III · Gen-Probe Inc
Key facts
| Event ID | 68229 |
|---|---|
| Recall numbers | Z-1793-2014 |
| Recalling firm | Gen-Probe Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however… |
| Initiation date | Apr 17, 2014 |
| Report date | Jun 25, 2014 |
| Termination date | Aug 26, 2014 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2024800 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: