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PerkinElmer Health Sciences, Inc. recalls PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Scree
Recalled August 13, 2014 · FDA recall Z-2166-2014 · PerkinElmer Health Sciences
Hazard
Potential for demographic information and test result to be mismatch. · FDA Class II
Units
13 devices
Sold at
Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
Description
Potential for demographic information and test result to be mismatch.
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.
Manufacturer(s)
PerkinElmer Health Sciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →