Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard¿...
FDA Device Recall #Z-2129-2015 — Class II — June 3, 2015
Recall Summary
| Recall Number | Z-2129-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 3, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Perkinelmer |
| Location | Waltham, MA |
| Product Type | Devices |
| Quantity | 18 units |
Product Description
Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Reason for Recall
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Distribution Pattern
Worldwide Distribution-US (nationwide) and the countries of ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CHINA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ETHIOPIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LUXEMBOURG MEXICO MYANMAR NETHERLANDS NORWAY PHILIPPINES POLAND REUNION SAUDIA ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UK.
Lot / Code Information
Serial Numbers: Model: 2470-0200 (13 units DG05129229 DG07118106 DG10129753 SGWZ01150228 SGWZ03140101 SGWZ03150234 SGWZ11140118 SGWZ21130011 SGWZ21130012 SGWZ28130023 SGWZ34140184 SGWZ34140185 SGWZ36130040 Model: 3470-0200 (5 units) DG08129543, DG11129863, SGWZ06150240,SGWZ30130027, SGWZ31130028
Other Recalls from Perkinelmer
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0635-2016 | Class II | Perkin Elmer WIZARD2 10-detector, 550 samples P... | Dec 8, 2015 |
| Z-0636-2016 | Class II | Perkin Elmer WIZARD2 5-detector, 1000 samples ... | Dec 8, 2015 |
| Z-0634-2016 | Class II | Perkin Elmer ClWIZARD2 5-detector, 550 samples ... | Dec 8, 2015 |
| Z-0637-2016 | Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples.... | Dec 8, 2015 |
| Z-0632-2016 | Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Pr... | Dec 8, 2015 |
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.