Recall Z-0638-2016
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 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Codes / lots: Serial Numbers: DG12107256 DG04106256 DG08118161 DG03117633 DG09118348 DG06117938 DG04106271 DG03117625 DG11118603 DG03129003 DG11107087 DG09118269 DG09118346 DG09118323 DG09118410 DG10118462 DG12118695 DG03129030 DG05117802 DG04129089 DG11107086 DG03117631 DG10118453 DG01117421 DG04106256_REWORK DG06106456 DG03106146 DG11118564 DG03129000 DG02106095 DG08106711 DG02128912 DG10106940 DG07118046 DG07118051 DG03117635 DG09118273 DG05117890 DG12118657 DG09118349 DG03117557 DG10118483 DG10118478 DG11107160 DG04129156 DG02106081 DG09118167 DG02128958 DG03129032 DG03117634 DG11118575 DG08118256 DG05106334 DG10106910 DG10106950 DG03117630 DG05106409 DG07106656 DG12107176 DG05106333 DG05117810 DG10106978 DG03106122 DG12107186 DG08106662 DG05117817 DG05117874 DG02128962 DG11118610 DG03129033 DG03129034 DG12118735 DG11107053 DG09118307 DG07118070 DG09118306 DG08118170 DG02128953 DG02128936 DG03129053 DG08118162 DG11118587 DG03129031 DG02128933 DG03129002 DG03129001 DG08118163 DG02128895 DG10118489 DG02117474 DG09118281 DG09118316 DG10106976 DG06117966 DG06106504 DG08118168 DG08118169 DG11118545 DG01128861 DG10118448 DG10118458 DG10118474 DG10118458 DG10118472 DG01128794 DG03129055…
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-0638-2016
- Initiated
- December 8, 2015
- Posted by FDA
- January 12, 2016
- Terminated
- August 4, 2017
- Product code
- JJJ – Counter (Beta, Gamma) For Clinical Use
- Quantity
- 188 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-0635-2016 Class II | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. 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 |