Device 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.
Z-2166-2014
Product summary
- Event
- Event 68670
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 devices
- Official record key
device-enforcement:Z-2166-2014
Official wording
Reason: Potential for demographic information and test result to be mismatch.
Code information: Product Code: 5002-0500; Software Versions, 1.4 and 1.6
Distribution pattern: Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
Derived failure modes
-
Unknown
Potential for demographic information and test result to be mismatch.