FDA Medical Device Recalls (openFDA)
Perkinelmer: WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
- Recall number
- Z-2125-2015
- Recalling firm
- Perkinelmer
- Product
- WIZARD2 2-detector, 550 samples Product Code: 2470-0020 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: DG01130042 DG01130083 DG01130122 DG02130179 DG03130196 DG03130242 DG04130300 DG04130318 DG05129208 DG05129239 DG05129251 DG05130343 DG06129284 DG06129320 DG07129407 DG07129433 DG08118247 DG08129522 DG08129575 DG09129612 DG09129619 DG09129643 DG10129707 DG10129728 DG10129768 DG11129836 DG11129838 DG12120004 DG12120038 SGWZ03150235 SGWZ04140103 SGWZ07140107 SGWZ07140108 SGWZ14140125 SGWZ16140131 SGWZ16140134 SGWZ20140150 SGWZ21140152 SGWZ27130022 SGWZ28140168 SGWZ29130026 SGWZ32130030 SGWZ33140183 SGWZ35140188 SGWZ36130039 SGWZ37130044 SGWZ39130048 SGWZ42130051 SGWZ43130053 SGWZ43130056 SGWZ44130057 SGWZ45130062 SGWZ47130076
- 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