WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamma counter is intende...
FDA Device Recall #Z-2125-2015 — Class II — June 3, 2015
Recall Summary
| Recall Number | Z-2125-2015 |
| 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 2-detector, 550 samples Product Code: 2470-0020 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: DG01130042 DG01130083 DG01130122 DG02130179 DG03130196 DG03130242 DG04130300 DG04130318 DG05129208 DG05129239 DG05129251 DG05130343 DG06129284 DG06129320 DG07129407 DG07129433 DG08118247 DG08129522 DG08129575 DG09129612 DG09129619 DG09129643 DG10129707 DG10129728 DG10129768 DG11129836 DG11129838 DG12120004 DG12120038 SGWZ03150235 SGWZ04140103 SGWZ07140107 SGWZ07140108 SGWZ14140125 SGWZ16140131 SGWZ16140134 SGWZ20140150 SGWZ21140152 SGWZ27130022 SGWZ28140168 SGWZ29130026 SGWZ32130030 SGWZ33140183 SGWZ35140188 SGWZ36130039 SGWZ37130044 SGWZ39130048 SGWZ42130051 SGWZ43130053 SGWZ43130056 SGWZ44130057 SGWZ45130062 SGWZ47130076
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.