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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70021

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

Open FDA event record

Event summary

Timeline bucket
May 20, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SCC Soft Computer

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

SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

Z-1038-2015
Recall number
Z-1038-2015
Initiated
May 20, 2014
Classification
Class II
Status
Terminated
Recalling firm
SCC Soft Computer
Quantity
48

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The interface fails to send abnormal flags for Reference Lab test results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The interface fails to send abnormal flags for Reference Lab test results.

Code information

4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present

Distribution pattern

Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.