Recall Z-2166-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
PerkinElmer Health Sciences, Inc.
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.
| Date | Aug 7, 2014 (initiated Jun 27, 2014) |
| Status | Terminated |
| Reason | Potential for demographic information and test result to be mismatch. |
| Root cause | Software design |
| Action | PerkinElmer sent an Urgent Medical Device Recall letter on July 1, 2014, to all affected customers. The letter informed customers of the recall and provided instructions. Customers were asked to complete the enclosed response form and fax it to 1-330-825-8520. For additional information, customers were instructed to contact their local PerkinElmer representative or email specimen.gate.support@perkinelmer.com. Customers with questions were instructed to call 1-800-321-9632. option 1. |
| Quantity | 13 devices |
| Distribution | Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.