CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report

Perkin Elmer WIZARD2 5-detector, 1 000 samples Product recalled

Perkinelmer is recalling Perkin Elmer WIZARD2 5-detector, 1 000 samples Product, distributed nationwide in the US. The recall was initiated on 3 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: Model: 2470-0150 (1 unit): SGWZ36130042 Model: 3470-0150 (1 unit): SGWZ19140141

Quantity recalled2 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-2128-2015
FDA event ID: 71380
Recalling firm: Perkinelmer, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 3 Jun 2015
FDA classified: 20 Jul 2015
Reported: 29 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Jun 2015	Recall initiated by company
20 Jul 2015	Classified by FDA	+47 days
29 Jul 2015	Published in enforcement report	+9 days

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

Reason for recall

Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results

Product as listed by the FDA

Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 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 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.

Nationwide

Questions about this recall

Is Perkin Elmer WIZARD2 5-detector, 1 000 samples Product recalled?

Yes. Perkinelmer recalled Perkin Elmer WIZARD2 5-detector, 1 000 samples Product on 3 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2128-2015.

Why was it recalled?

Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results

Which lots are affected?

Serial Numbers: Model: 2470-0150 (1 unit): SGWZ36130042 Model: 3470-0150 (1 unit): SGWZ19140141

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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