Perkinelmer recalls Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is intended to detect and…

Recall date

December 8, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0633-2016

FDA classification

Class II

Brand / firm

Perkinelmer

Sold / distributed

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, PO…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Perkin Elmer 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