Home / Recalls / PerkinElmer Health Sciences, Inc. / Z-2166-2014

Z-2166-2014 Class II Terminated

Recalled by PerkinElmer Health Sciences, Inc. — Waltham, MA

Recall Details

Product Type
Devices
Report Date
August 13, 2014
Initiation Date
June 27, 2014
Termination Date
April 6, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 devices

Product Description

PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

Reason for Recall

Potential for demographic information and test result to be mismatch.

Distribution Pattern

Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK

Code Information

Product Code: 5002-0500; Software Versions, 1.4 and 1.6

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  • Z-0902-2017 Class II — Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software V (December 1, 2016)
  • Z-0779-2017 Class III — DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum (November 16, 2016)
  • Z-2153-2014 Class II — Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for (July 1, 2014)