Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is i
FDA device recall Z-0902-2017 · posted 2016-12-23 · Terminated
Recall details
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Reason for recall
- Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
- Action taken
- PerkinElmer Health Sciences issued a Medical Device Correction letter dated December 1, 2016, to all affected customers email facilitated through our PerkinElmer Software Services group located in Akron Ohio. Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures. Actions to be taken A field correction of the issue is recommended. PerkinElmer will correct the issue with an update installed through remote connection. You will be contacted by your PerkinElmer representative to make the necessary arrangements for implementing the update. In the interim period, please do not attempt to login multiple times in quick succession. Allow the software time to respond to first login command. Please contact your local PerkinElmer representative or Specimen Gate Support for further information. Other Information Please inform those affected in your organization accordingly. To comply with regulatory requirements we request that you complete the enclosed response form and return it by fax to number 1-330-825-8520 (United States) /+358 2 2678 357 (outside United States) or as scanned by e-mail to TurkuQMresponse@perkinelmer.com as soon as possible, but not later than December 22, 2016. For questions regarding this recall call 781-663-6900.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 21
- Distribution
- Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru
- Date initiated
- 2016-12-01
- Date posted
- 2016-12-23
- Date terminated
- 2017-05-01
- Location
- Waltham, MA
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