FDAClass IIJuly 29, 2015

Perkin Elmer WIZARD2 10-detector recall

Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gamma counter is intended to detect and count gamma…

Why was Perkin Elmer WIZARD2 10-detector recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: Model: 2470-0100 (51 units) DG01130134 DG02130152 DG03130216 DG03130255 DG04130263 DG04130279 DG04130289 DG04130328 DG05129261 DG06106456 DG06129310 DG08129556 DG10129701 DG10129780 DG11129850 DG11129872 DG12118702 DG12120031 DG12129891 SGWZ02140093 SGWZ02140094 SGWZ03140098 SGWZ03140099 SGWZ03140100 SGWZ05140104 SGWZ06150243 SGWZ07150244 SGWZ09150248 SGWZ10150252 SGWZ11150255 SGWZ12130001 SGWZ16140132 SGWZ17140137 SGWZ19140144 SGWZ20140148 SGWZ21130009 SGWZ21140151 SGWZ24130019 SGWZ27130021 SGWZ27140166 SGWZ29140171 SGWZ31140175 SGWZ34130035 SGWZ36130038 SGWZ37140196 SGWZ45130061 SGWZ45130067 SGWZ48140219 SGWZ49140222 SGWZ50130086 SGWZ52130091 Model: 3470-0100 (3 units) DG11129817, SGWZ21130010,SGWZ27140163

Product
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gamma counter is intended to detect and count gamma…
Recalling firm
Perkinelmer
Quantity
54 units
Distribution
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.
Recall date
July 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls