Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0635-2016 — Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples

U.S. FDA — Device Enforcement · United States · 2015-12-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0635-2016
Date of alert
2015-12-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Perkinelmer
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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