Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma c...
FDA Device Recall #Z-2130-2015 — Class II — June 3, 2015
Recall Summary
| Recall Number | Z-2130-2015 |
| 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 | 179 units |
Product Description
Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 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: DG01130076 DG01130081 DG01130107 DG01130113 DG02130148 DG02130157 DG02130171 DG02130172 DG02130174 DG02130176 DG03129032 DG03130218 DG03130220 DG03130223 DG03130225 DG03130227 DG03130240 DG03130247 DG04106271 DG04129101 DG04129141 DG04129168 DG05129187 DG05129210 DG05129256 DG05129258 DG06117938 DG06129274 DG06129282 DG06129289 DG06129333 DG06129336 DG06129341 DG06129343 DG06129345 DG06129346 DG06129354 DG07129436 DG07129444 DG07129445 DG07129446 DG07129448 DG07129449 DG08118168 DG08118169 DG08129491 DG08129502 DG08129505 DG08129506 DG08129544 DG08129545 DG08129595 DG09129607 DG09129622 DG09129623 DG09129644 DG10129700 DG10129708 DG10129717 DG10129726 DG10129759 DG10129763 DG10129777 DG10129784 DG11095721 DG11129816 DG11129823 DG11129839 DG11129854 DG12120039 DG12129887 DG12129893 DG12129902 DG12129903 DG12129904 DG12129905 DG12129931 DG12129932 SGWZ02140095 SGWZ02140096 SGWZ02140097 SGWZ02150231 SGWZ03150233 SGWZ04150236 SGWZ04150237 SGWZ07140106 SGWZ07150245 SGWZ08140109 SGWZ08140110 SGWZ08140111 SGWZ08150246 SGWZ09140112 SGWZ10140115 SGWZ10150250 SGWZ11150253 SGWZ12140120 SGWZ12140121 SGWZ12140122 SGWZ13140123 SGWZ13140124 SGWZ14130004 SGWZ15140127 SGWZ15140129 SGWZ17130005 SGWZ18140138 SGWZ19140142 SGWZ19140143 SGWZ20130008 SGWZ20140146 SGWZ20140149 SGWZ21140153 SGWZ22130013 SGWZ22130014 SGWZ22140155 SGWZ22140156 SGWZ23130015 SGWZ23140157 SGWZ24140158 SGWZ25130020 SGWZ27140162 SGWZ27140165 SGWZ28140167 SGWZ29140170 SGWZ30140172 SGWZ30140173 SGWZ31130029 SGWZ31140177 SGWZ31140178 SGWZ32130031 SGWZ32140181 SGWZ32140182 SGWZ33130032 SGWZ33130033 SGWZ34140186 SGWZ35130037 SGWZ35140187 SGWZ35140189 SGWZ36130041 SGWZ36140191 SGWZ36140194 SGWZ37130045 SGWZ37140195 SGWZ39130047 SGWZ39140197 SGWZ39140198 SGWZ40140199 SGWZ40140200 SGWZ41130049 SGWZ42130050 SGWZ42140201 SGWZ42140202 SGWZ42140203 SGWZ43130055 SGWZ44130059 SGWZ44130060 SGWZ44140210 SGWZ44140211 SGWZ45130064 SGWZ45130066 SGWZ45140212 SGWZ45140213 SGWZ45140214 SGWZ46130069 SGWZ46130070 SGWZ46130071 SGWZ46130072 SGWZ47130073 SGWZ47130074 SGWZ48140220 SGWZ48140221 SGWZ49130081 SGWZ49130082 SGWZ49130083 SGWZ49140223 SGWZ50130084 SGWZ51130089 SGWZ51130090 SGWZ51140224 SGWZ52140225
Other Recalls from Perkinelmer
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0632-2016 | Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Pr... | 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-0638-2016 | Class II | Perkin Elmer WIZARD2 1-detector,3", 1000 sample... | Dec 8, 2015 |
| Z-0635-2016 | Class II | Perkin Elmer WIZARD2 10-detector, 550 samples P... | 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.