Recall Z-2130-2015
Perkinelmer · initiated June 3, 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: DG01130076 DG01130081 DG01130107 DG01130113 DG02130148 DG02130157 DG02130171 DG02130172 DG02130174 DG02130176 DG03129032 DG03130218 DG03130220 DG03130223 DG03130225 DG03130227 DG03130240 DG03130247 DG04106271 DG04129101 DG04129141 DG04129168 DG05129187 DG05129210 DG05129256 DG05129258 DG06117938 DG06129274 DG06129282 DG06129289 DG06129333 DG06129336 DG06129341 DG06129343 DG06129345 DG06129346 DG06129354 DG07129436 DG07129444 DG07129445 DG07129446 DG07129448 DG07129449 DG08118168 DG08118169 DG08129491 DG08129502 DG08129505 DG08129506 DG08129544 DG08129545 DG08129595 DG09129607 DG09129622 DG09129623 DG09129644 DG10129700 DG10129708 DG10129717 DG10129726 DG10129759 DG10129763 DG10129777 DG10129784 DG11095721 DG11129816 DG11129823 DG11129839 DG11129854 DG12120039 DG12129887 DG12129893 DG12129902 DG12129903 DG12129904 DG12129905 DG12129931 DG12129932 SGWZ02140095 SGWZ02140096 SGWZ02140097 SGWZ02150231 SGWZ03150233 SGWZ04150236 SGWZ04150237 SGWZ07140106 SGWZ07150245 SGWZ08140109 SGWZ08140110 SGWZ08140111 SGWZ08150246 SGWZ09140112 SGWZ10140115 SGWZ10150250 SGWZ11150253 SGWZ12140120 SGWZ12140121 SGWZ12140122 SGWZ13140123 SGWZ13140124 SGWZ14130004 SGWZ15140127 SGWZ15140129…
Reason for recall
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
FDA-determined cause: Nonconforming Material/Component
Action taken
Perkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com
Details
- Recall number
- Z-2130-2015
- Initiated
- June 3, 2015
- Posted by FDA
- July 20, 2015
- Terminated
- August 4, 2017
- Product code
- JJJ – Counter (Beta, Gamma) For Clinical Use
- Quantity
- 179 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…
- Recalling firm
- Perkinelmer, Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2124-2015 Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard" gamma…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2125-2015 Class II | WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard" gamma counter is…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2126-2015 Class II | WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard" gamma…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2127-2015 Class II | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2128-2015 Class II | Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |
| Z-2129-2015 Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | 06/03/2015Terminated |