The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid test...
FDA Device Recall #Z-0948-2015 — Class II — November 23, 2013
Recall Summary
| Recall Number | Z-0948-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 23, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abbott Molecular |
| Location | Des Plaines, IL |
| Product Type | Devices |
| Quantity | 176 devices |
Product Description
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Reason for Recall
The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.
Distribution Pattern
Worldwide Distribution - USA including CA, FL, GA, IL, MI, NC, NJ, NY, OH, OK, OR, and TX and Internationally to Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, China, Colombia, Costa Rica, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Indonesia, Ireland, Israel, Italy, Kazakhstan, Kenya, Malawi, Mali, Mexico, Morocco, Mozambique, New Zealand, Nigeria, Norway, Pakistan, Poland, Russia, Saudi Arabia, Senegal, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
Lot / Code Information
List Number: 09K14-02; Model: E-series; Serial Numbers: 10664 - 10833, 1004, 1005, 10142, 10154, 10171, 10416
Other Recalls from Abbott Molecular
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0463-2015 | Class II | Abbott m2000sp, an automated system for perform... | Oct 23, 2014 |
| Z-2169-2014 | Class II | 5 mL Reaction Vessels (a consumable of the Abbo... | Jun 19, 2014 |
| Z-1491-2014 | Class III | The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20u... | Mar 28, 2013 |
| Z-0634-2013 | Class II | Abbott m2000sp Instrument; an automated fluid h... | Dec 4, 2012 |
| Z-2013-2012 | Class II | Abbott Molecular Bar Code Scanner User's Guide;... | Jan 31, 2012 |
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.