Home / Recalls / Perkinelmer / Z-0637-2016

Z-0637-2016 Class II Terminated

Recalled by Perkinelmer — Waltham, MA

FDA device recall Z-0637-2016 was initiated by Perkinelmer on December 8, 2015 and is designated Class II. 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 protoc… The recall status is terminated (terminated August 4, 2017). Affected quantity: 22 units.

Recall Details

Product Type: Devices
Report Date: January 20, 2016
Initiation Date: December 8, 2015
Termination Date: August 4, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22 units

Product Description

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

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.

Distribution Pattern

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, TAIWAN, and THAILAND.

Code Information

Serial Numbes: DG08118243 DG12118732 DG09106871 DG03117554 DG05106373 DG02117481 DG11107153 DG07118106 DG03128981 DG04106316 DG03117574 DG04106296 DG04117674 DG05106414 DG02117455 DG07106607 DG11107048 DG03106163 DG07106604 DG05117805 DG08106759 DG03129008

Other recalls by Perkinelmer

Z-0780-2017 Class II — PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. U (October 13, 2016)
Z-0747-2017 Class II — Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized (June 24, 2016)
Z-0634-2016 Class II — Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-00 (December 8, 2015)
Z-0633-2016 Class II — Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard (December 8, 2015)
Z-0635-2016 Class II — Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 (December 8, 2015)
Z-0632-2016 Class II — Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard (December 8, 2015)
Z-0636-2016 Class II — Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-015 (December 8, 2015)
Z-0638-2016 Class II — Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The (December 8, 2015)
Z-2130-2015 Class II — Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The (June 3, 2015)
Z-2127-2015 Class II — Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-010 (June 3, 2015)