CLASS II Device recall · Reported 20 Jan 2016 · FDA Enforcement Report

Perkin Elmer WIZARD2 1-detector, 550 samples Product recalled

Perkinelmer is recalling Perkin Elmer WIZARD2 1-detector, 550 samples Product, distributed nationwide in the US. The recall was initiated on 8 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: DG06106539 DG12118720 DG07106646 DG12107250 DG12107281 DG03117619 DG11118605 DG01117400 DG12107202 DG01117401 DG06106449 DG03117666 DG05117791 DG06106454 DG03106180 DG11118637 DG07118121 DG07106598 DG11118633 DG06106520 DG03106137 DG07118111 DG02128888 DG08118247 DG06118014 DG01128790 DG12107207 DG07106637 DG01128876 DG04117764 DG01106035 DG12118780 DG05106342 DG01117399 DG06117909 DG06118011 DG09106846 DG11107146 DG12118694 DG08118217 DG02106084 DG04117690 DG05117838 DG09106799 DG04117735 DG03117548 DG01117362

Quantity recalled47 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0632-2016
FDA event ID: 72808
Recalling firm: Perkinelmer, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 8 Dec 2015
FDA classified: 12 Jan 2016
Reported: 20 Jan 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Dec 2015	Recall initiated by company
12 Jan 2016	Classified by FDA	+35 days
20 Jan 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples

Where it was distributed

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.

Nationwide

Questions about this recall

Is Perkin Elmer WIZARD2 1-detector, 550 samples Product recalled?

Yes. Perkinelmer recalled Perkin Elmer WIZARD2 1-detector, 550 samples Product on 8 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0632-2016.

Why was it recalled?

Which lots are affected?

Serial Numbers: DG06106539 DG12118720 DG07106646 DG12107250 DG12107281 DG03117619 DG11118605 DG01117400 DG12107202 DG01117401 DG06106449 DG03117666 DG05117791 DG06106454 DG03106180 DG11118637 DG07118121 DG07106598 DG11118633 DG06106520 DG03106137 DG07118111 DG02128888 DG08118247 DG06118014 DG01128790 DG12107207 DG07106637 DG01128876 DG04117764 DG01106035 DG12118780 DG05106342 DG01117399 DG06117909 DG06118011 DG09106846 DG11107146 DG12118694 DG08118217 DG02106084 DG04117690 DG05117838 DG09106799 DG04117735 DG03117548 DG01117362

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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