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

Perkin Elmer WIZARD2 10-detector, 550 samples Product recalled

Perkinelmer is recalling Perkin Elmer WIZARD2 10-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 codesModel Number: 2470-0100 Serial Numbers: DG06106436 DG08118240 DG02106050 DG06106502 DG11118609 DG01128795 DG02117461 DG12118702 DG09106861 DG05117833 DG05117834 DG10107006 DG06106452 DG09118367 DG03106154 DG04129081 DG06106559 DG06117903 DG07106599 DG09106774 DG05106387 DG06106524 DG10106949 DG09118284 DG05117787 DG04117755 DG09106770 DG03106196 DG04129159 DG08118192 DG06106469 DG08118189 DG04129075 DG12107252 DG12118677 DG06117923 DG08106741 DG03106186 DG12118759 DG01117444 DG02106112 DG12107236 DG11107031 DG12107249 DG11118612 DG05117781 Model: 3470-0100 (1 unit) Serial Number: DG02128911

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-0635-2016
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 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. 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 10-detector, 550 samples Product recalled?

Yes. Perkinelmer recalled Perkin Elmer WIZARD2 10-detector, 550 samples Product on 8 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0635-2016.

Why was it recalled?

Which lots are affected?

Model Number: 2470-0100 Serial Numbers: DG06106436 DG08118240 DG02106050 DG06106502 DG11118609 DG01128795 DG02117461 DG12118702 DG09106861 DG05117833 DG05117834 DG10107006 DG06106452 DG09118367 DG03106154 DG04129081 DG06106559 DG06117903 DG07106599 DG09106774 DG05106387 DG06106524 DG10106949 DG09118284 DG05117787 DG04117755 DG09106770 DG03106196 DG04129159 DG08118192 DG06106469 DG08118189 DG04129075 DG12107252 DG12118677 DG06117923 DG08106741 DG03106186 DG12118759 DG01117444 DG02106112 DG12107236 DG11107031 DG12107249 DG11118612 DG05117781 Model: 3470-0100 (1 unit) Serial Number: DG02128911

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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