VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5...
FDA Device Recall #Z-0989-2013 — Class II — February 18, 2013
Recall Summary
| Recall Number | Z-0989-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 18, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomerieux Inc |
| Location | Hazelwood, MO |
| Product Type | Devices |
| Quantity | For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed |
Product Description
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, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Reason for Recall
There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Distribution Pattern
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.
Lot / Code Information
Manufactured from September, 2004, to present.
Other Recalls from Biomerieux Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1236-2026 | Class II | VITEK 2 Gram-negative Susceptibility Cards Cont... | Jan 5, 2026 |
| Z-1464-2024 | Class I | VITEK 2 - AST Test kits (in vitro diagnostic te... | Mar 14, 2024 |
| Z-1201-2023 | Class II | MYLA comprises AST Filters in conjunction with ... | Feb 6, 2023 |
| Z-0798-2023 | Class II | VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700 | Nov 9, 2022 |
| Z-0786-2023 | Class II | API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 | Nov 9, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.