Specimen Gate Laboratory 5002-0180 — Class II medical device recall Z-0902-2017
Terminated recall by PerkinElmer Health Sciences, Inc., reported 2017-01-04, distributed in AZ, CO, FL, GA, IL, KY, MA, MI…. Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
| Recall number | Z-0902-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PerkinElmer Health Sciences, Inc., Waltham, MA, United States |
| Recall initiated | 2016-12-01 |
| Classified | 2016-12-23 |
| Reported by FDA | 2017-01-04 |
| Terminated | 2017-05-01 |
| Distributed | AZ, CO, FL, GA, IL, KY, MA, MI, NJ, NV, OH, SC |
| Countries outside the US | ES, GB, IE, IT, PE |
| Quantity | 21 |
| Reason classes | software |
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 for recall
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0902-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.