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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63369

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

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Event summary

Timeline bucket
November 03, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sunquest Information Systems, 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

Sunquest Laboratory, version 7.0 not available

Z-0250-2013
Recall number
Z-0250-2013
Initiated
November 03, 2011
Classification
Class II
Status
Terminated
Quantity
14 sites

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

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

Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

Code information

not available

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Ireland