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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76648

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

Open FDA event record

Event summary

Timeline bucket
March 07, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
PerkinElmer Life and Analytical Sciences, Wallac, OY

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; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.

Z-1761-2017
Recall number
Z-1761-2017
Initiated
March 07, 2017
Classification
Class II
Status
Terminated
Quantity
29

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.

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 errors in patient results generated by the Specimen Gate Laboratory Software.

Code information

Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2

Distribution pattern

Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil