Medical device recalls Moderate risk

Perkinelmer recalls Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect a…

Recall date
June 3, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2124-2015
FDA classification
Class II
Brand / firm
Perkinelmer
Sold / distributed
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 NETHER…

Why it was recalled

Error in WIZARD2 Barcode ID Label #023 Content 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 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.

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