Exact FDA event identifier

Event 75817

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: December 01, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: PerkinElmer Health Sciences, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0902-2017

Recall number: Z-0902-2017
Initiated: December 01, 2016
Classification: Class II
Status: Terminated
Recalling firm: PerkinElmer Health Sciences, Inc.
Quantity: 21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Software Version 1.0

Distribution pattern

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