Recall Z-2166-2014— PerkinElmer Health Sciences, Inc.

Name: FDA recall Z-2166-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-27

Class II · Terminated

Class II FDA medical device recall by PerkinElmer Health Sciences, Inc., initiated 2014-06-27, terminated 2015-04-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for demographic information and test result to be mismatch..

Recalling firm: PerkinElmer Health Sciences, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-27
Terminated: 2015-04-06
Firm location: Waltham, MA, United States

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.

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