Recall record at a glance
| Official record | Z-0991-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Biomerieux Inc. |
| Report date | Apr 3, 2013 |
| Recall initiation date | Feb 18, 2013 |
| Quantity | For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed |
| Location | Hazelwood, MO, United States |
Official product description
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. #W0447; (4) dc7700 8-port (refurbished), Cat. #W0447R; (5) dc7800, Cat. #W0449; (6) dc7800 (refurbished), Cat. #W0449R (7) rp5700, Cat. #W0452; (8) rp5700 (refurbished), Cat. #W0452R; (9) rp5800 XPE, Cat. 413642; (10) rp5800WES7, Cat. #413862; (11) d530 6-port, Cat. #W0438; (12) d530 6-port (refurbished), Cat. #W0438R; and (13) d530 4-port, Cat. #W0437. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Why the product was recalled
There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Distribution information
Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina Faso, Camaroun, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Democratic Republic of Congo, Demark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Netherlands, Netherlands, Nicaragua, Niger Niamey, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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