Drug recall
VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat…
FDA recall event 64394 · Class II · Biomerieux Inc
Key facts
| Event ID | 64394 |
|---|---|
| Recall numbers | Z-0989-2013, Z-0990-2013, Z-0991-2013 |
| Recalling firm | Biomerieux Inc |
| Product type | Devices |
| Products | VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7…, VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (refurbished), Cat. #W0441R; (3) dc7700 8-port, Cat…, VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS. |
| Initiation date | Feb 18, 2013 |
| Report date | Apr 3, 2013 |
| Termination date | Aug 14, 2014 |
| City | Hazelwood |
| State | MO |
| Country | United States |
| FEI number | 1950204 |
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: