FDA Medical Device Recalls (openFDA)
PerkinElmer Health Sciences, Inc.: Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports
- Recall number
- Z-0902-2017
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Product
- Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports
- Status
- Terminated
- Initiated
- 2016-12-01
- Posted
- 2016-12-23
- Terminated
- 2017-05-01
- Reason
- Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 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
- Lot, serial or model codes
- Software Version 1.0
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3006159931
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28