FDA Device recall Z-0902-2017
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as…
- FDA Device
- Class II
- terminated
- Published 2017-01-04
On 2017-01-04 the FDA classified a Class II recall of Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as… by Perkinelmer Health Sciences, citing issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0902-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-01 |
| Published | 2017-01-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Perkinelmer Health Sciences |
| Distribution | AZ, CO, FL, GA, IL, KY, MA, MI, NJ, NV, OH, SC |
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.
Identifiers
| code_info | Software Version 1.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0902-2017%22
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