Recall Z-0635-2016
Perkinelmer · initiated December 8, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 radiation emitted by clinical samples
Codes / lots: 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
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Perkin Elmer sent an Urgent Medical Device Correction letter dated December 7, 2015 to affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to destroy all affected products in their possession. Customers were asked to complete the enclosed Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com . Corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. For further information contact your local PerkinElmer representatives..
Details
- Recall number
- Z-0635-2016
- Initiated
- December 8, 2015
- Posted by FDA
- January 12, 2016
- Terminated
- August 4, 2017
- Product code
- JJJ – Counter (Beta, Gamma) For Clinical Use
- Quantity
- 47 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…
- Recalling firm
- Perkinelmer, Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0632-2016 Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0633-2016 Class II | Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0634-2016 Class II | Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0636-2016 Class II | Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0637-2016 Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |
| Z-0638-2016 Class II | Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | 12/08/2015Terminated |