FDA Medical Device Recalls (openFDA)
Perkinelmer: Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
- Recall number
- Z-2129-2015
- Recalling firm
- Perkinelmer
- 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 radiation emitted by clinical samples.
- Status
- Terminated
- Initiated
- 2015-06-03
- Posted
- 2015-07-20
- Terminated
- 2017-08-04
- Reason
- Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
- Root cause
- Nonconforming Material/Component
- Action
- 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
- Quantity
- 18 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.
- Lot, serial or model codes
- Serial Numbers: Model: 2470-0200 (13 units DG05129229 DG07118106 DG10129753 SGWZ01150228 SGWZ03140101 SGWZ03150234 SGWZ11140118 SGWZ21130011 SGWZ21130012 SGWZ28130023 SGWZ34140184 SGWZ34140185 SGWZ36130040 Model: 3470-0200 (5 units) DG08129543, DG11129863, SGWZ06150240,SGWZ30130027, SGWZ31130028
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJJ
- Firm FEI
- 3006159931
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28