FDA-Device2016-01-20Class II
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
Perkinelmer
Hazard
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.
Sold states
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.
Affected count
47 units
Manufactured in
940 Winter Street, N/A, Waltham, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0632-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief