Recall Z-0902-2017— PerkinElmer Health Sciences, Inc.
Class II · Terminated
Class II FDA medical device recall by PerkinElmer Health Sciences, Inc., initiated 2016-12-01, terminated 2017-05-01. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating..
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-01
- Terminated
- 2017-05-01
- Firm location
- Waltham, MA, United States
Product description
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
Reason for recall
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
Data sourced from openFDA. This site is unofficial and independent of the FDA.