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Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is...

FDA Device Recall #Z-0633-2016 — Class II — December 8, 2015

Recall Summary

Recall Number Z-0633-2016
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 60 units

Product Description

Perkin Elmer 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

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 Numbers: DG02117524 DG09118363 DG08118156 DG08118195 DG02128922 DG10118375 DG12107235 DG08118222 DG02117537 DG08118184 DG09106872 DG11107116 DG03117626 DG03117611 DG01117425 DG12107293 DG09118332 DG06106503 DG06118006 DG01128820 DG12118707 DG05106427 DG03106166 DG11118630 DG01117434 DG09106779 DG02117500 DG12118742 DG06106477 DG03106208 DG09106800 DG10106903 DG05117853 DG03117671 DG06106473 DG04117754 DG04117698 DG11118538 DG11118617 DG01117392 DG03117644 DG05117882 DG03117655 DG04117683 DG02106106 DG05106347 DG06118043 DG10118385 DG08106671 DG01128869 DG06118023 DG05106328 DG02117516 DG11107142 DG05106354 DG08118254 DG03106181 DG03106197 DG02117505 DG11107105

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.

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