Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard ...
FDA Device Recall #Z-0637-2016 — Class II — December 8, 2015
Recall Summary
| Recall Number | Z-0637-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 8, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Perkinelmer |
| Location | Waltham, MA |
| Product Type | Devices |
| Quantity | 22 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
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.
Lot / Code Information
Serial Numbes: DG08118243 DG12118732 DG09106871 DG03117554 DG05106373 DG02117481 DG11107153 DG07118106 DG03128981 DG04106316 DG03117574 DG04106296 DG04117674 DG05106414 DG02117455 DG07106607 DG11107048 DG03106163 DG07106604 DG05117805 DG08106759 DG03129008
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-0633-2016 | Class II | Perkin Elmer WIZARD2 2-detector, 550 samples Pr... | 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.