WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard¿" gamma counter...
FDA Device Recall #Z-2126-2015 — Class II — June 3, 2015
Recall Summary
| Recall Number | Z-2126-2015 |
| 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 | 53 units |
Product Description
WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 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: DG03130211 DG04130287 DG05130344 DG06129306 DG08129516 DG08129541 DG08129542 DG08129582 DG08129593 DG10129714 DG10129720 DG11095720 DG12118684 DG12129915 DG12129916 DG12129917 DG12129918 SG24700050 SGWZ01150227 SGWZ02150229 SGWZ02150230 SGWZ03150232 SGWZ04140102 SGWZ06140105 SGWZ10150251 SGWZ11140117 SGWZ11140119 SGWZ12130002 SGWZ16140130 SGWZ16140133 SGWZ17140136 SGWZ19140145 SGWZ20130007 SGWZ21140154 SGWZ24140160 SGWZ25140161 SGWZ29140169 SGWZ30140174 SGWZ31140176 SGWZ34130036 SGWZ39130046 SGWZ42130052 SGWZ42140205 SGWZ42140206 SGWZ43130054 SGWZ43140208 SGWZ43140209 SGWZ46140215 SGWZ46140216 SGWZ47140217 SGWZ47140218 SGWZ48130079 SGWZ50130085
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.