Exact FDA event identifier

Event 68670

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

Open FDA event record

Event summary

Timeline bucket: June 27, 2014
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

PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

Z-2166-2014

Recall number: Z-2166-2014
Initiated: June 27, 2014
Classification: Class II
Status: Terminated
Recalling firm: PerkinElmer Health Sciences, Inc.
Quantity: 13 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for demographic information and test result to be mismatch.

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

Potential for demographic information and test result to be mismatch.

Code information

Product Code: 5002-0500; Software Versions, 1.4 and 1.6

Distribution pattern

Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK