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Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 ...

FDA Device Recall #Z-0634-2016 — Class II — December 8, 2015

Recall Summary

Recall Number Z-0634-2016
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 62 units

Product Description

Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 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

Model: 2470-0050 Serial Numbers: DG05106329 DG02117493 DG11107166 DG09106782 DG07118133 DG07118141 DG09106791 DG04117727 DG06118036 DG12107192 DG02106101 DG04106223 DG01128843 DG12107272 DG07118124 DG09106892 DG12118684 DG12118673 DG11107126 DG04117704 DG04117763 DG01117363 DG06106484 DG12107240 DG01128871 DG05117880 DG12118685 DG09118357 DG03106204 DG05106386 DG11107137 DG03106172 DG03106206 DG02106113 DG09106818 DG02106065 DG04106309 DG09106882 DG11118590 DG06106483 DG01117316 DG08118221 DG06117898 DG12107263 DG08118250 DG12118711 DG04117710 DG06106448 DG06106453 DG06106463 DG06117912 DG03106135 DG01117373 DG05117837 DG06106517 DG01128805 DG06117970 DG04106310 DG02117521 DG06106538 Model: 3470-0050 (2 units) Serial Numbers: DG12118660 DG10118464

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-0633-2016 Class II Perkin Elmer WIZARD2 2-detector, 550 samples Pr... 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.

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