13
Aug
2014

PerkinElmer Specimen Gate Screening SW Cl II

0

Company: PerkinElmer Health Sciences Inc
Date of Enforcement Report: 8/16/2014
Class lI:

PRODUCT

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.
Recall Number Z-2166-2014

REASON
Potential for demographic information and test result to be mismatch.

RECALLING FIRM/MANUFACTURER
PerkinElmer Health Sciences Inc, Waltham, MA. on 6/27/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
13 devices

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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