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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67628

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

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Event summary

Timeline bucket
February 17, 2014
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Technidata S.A.

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

TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).

Z-1310-2014
Recall number
Z-1310-2014
Initiated
February 17, 2014
Classification
Class III
Status
Terminated
Recalling firm
Technidata S.A.
Quantity
85 units total (1 unit in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument.

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

If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument.

Code information

version 11.01.A or higher

Distribution pattern

Distributed in the state of PA.