Z-2166-2014 Class II Terminated
FDA device recall Z-2166-2014 was initiated by PerkinElmer Health Sciences, Inc. on June 27, 2014 and is designated Class II. Reason for recall: Potential for demographic information and test result to be mismatch. The recall status is terminated (terminated April 6, 2015). Affected quantity: 13 devices.
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