FDAClass IIJanuary 20, 2016

Perkin Elmer WIZARD2 10-detector recall

Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gamma counter is intended to detect and count gamma…

Why was Perkin Elmer WIZARD2 10-detector recalled?

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.

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 Numbes: DG08118243 DG12118732 DG09106871 DG03117554 DG05106373 DG02117481 DG11107153 DG07118106 DG03128981 DG04106316 DG03117574 DG04106296 DG04117674 DG05106414 DG02117455 DG07106607 DG11107048 DG03106163 DG07106604 DG05117805 DG08106759 DG03129008

Product
Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gamma counter is intended to detect and count gamma…
Recalling firm
Perkinelmer
Quantity
22 units
Distribution
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.
Recall date
January 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls