Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard" gamma counter is intended to detect and

FDA device recall Z-2124-2015 · posted 2015-07-20 · Terminated

Recall details

Recalling firm

Perkinelmer

Reason for recall

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

Action taken

Perkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JJJ

Quantity affected

63 units

Distribution

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 GREE

Date initiated

2015-06-03

Date posted

2015-07-20

Date terminated

2017-08-04

Location

Waltham, MA