Recall Z-2127-2015— Perkinelmer

Name: FDA recall Z-2127-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-03

Class II · Terminated

Class II FDA medical device recall by Perkinelmer, initiated 2015-06-03, terminated 2017-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results.

Recalling firm: Perkinelmer
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Terminated: 2017-08-04
Firm location: Waltham, MA, United States

Product description

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.

Reason for recall

Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results

Data sourced from openFDA. This site is unofficial and independent of the FDA.