Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Labo

U.S. FDA — Device Enforcement · United States · 2016-12-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0902-2017
Date of alert: 2016-12-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: PerkinElmer Health Sciences, Inc.
Product category: device
Product type: Devices

Reported risk: Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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