PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screenin
FDA device recall Z-2166-2014 · posted 2014-08-07 · Terminated
Recall details
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Reason for recall
- Potential for demographic information and test result to be mismatch.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 13 devices
- Distribution
- Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
- Date initiated
- 2014-06-27
- Date posted
- 2014-08-07
- Date terminated
- 2015-04-06
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.