Perkinelmer: Medical Device Recall in 2016 - (Recall #: Z-0636-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples

Product Classification:

Class II

Date Initiated: December 8, 2015

Date Posted: January 20, 2016

Recall Number: Z-0636-2016

Event ID: 72808

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.

Status: Terminated

Product Quantity: 4 units

Code Information:

Serial Numbers: DG04129084 DG12118776 DG04117773 DG05106408

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.

Voluntary or Mandated:

Voluntary: Firm initiated