FDA Medical Device Recalls (openFDA)
Perkinelmer: WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
- Recall number
- Z-2126-2015
- Recalling firm
- Perkinelmer
- Product
- WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 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
- 53 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: DG03130211 DG04130287 DG05130344 DG06129306 DG08129516 DG08129541 DG08129542 DG08129582 DG08129593 DG10129714 DG10129720 DG11095720 DG12118684 DG12129915 DG12129916 DG12129917 DG12129918 SG24700050 SGWZ01150227 SGWZ02150229 SGWZ02150230 SGWZ03150232 SGWZ04140102 SGWZ06140105 SGWZ10150251 SGWZ11140117 SGWZ11140119 SGWZ12130002 SGWZ16140130 SGWZ16140133 SGWZ17140136 SGWZ19140145 SGWZ20130007 SGWZ21140154 SGWZ24140160 SGWZ25140161 SGWZ29140169 SGWZ30140174 SGWZ31140176 SGWZ34130036 SGWZ39130046 SGWZ42130052 SGWZ42140205 SGWZ42140206 SGWZ43130054 SGWZ43140208 SGWZ43140209 SGWZ46140215 SGWZ46140216 SGWZ47140217 SGWZ47140218 SGWZ48130079 SGWZ50130085
- 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