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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 56447

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

Open FDA event record

Event summary

Timeline bucket
July 29, 2010
Product types
Device
Classifications
Class II
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

TD-Synergy. Laboratory Information System.

Z-1345-2013
Recall number
Z-1345-2013
Initiated
July 29, 2010
Classification
Class II
Status
Terminated
Recalling firm
Technidata S.A.
Quantity
10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request.

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

Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request.

Code information

TD Lims product versions: LIS (ALLX)-21.041-_ML-5370, LIS (ALLX)-22.021-_ML-5374, TD-Synergy product versions: SYN (ALLX)- 03.13B-_ML-5368, SYN (ALLX)- 03.141-_ML-5369, SYN(LINUX)-06.011-_ML-5381, SYN (ALLX)-11.11B-_ML-5345, SYN (ALLX)-11.21B-_ML-5346 SYN (ALL)- 11.31C-_ML-5372, SYN (LINUX)-11.321-_FR-5382, SYN (ALL)-11.321-_ML-5373

Distribution pattern

Worldwide Distribution-USA (nationwide) including Washington DC and the states of California, Nevada, Kentucky, Alabama, Rhode Island, Pennsylvania, and Louisiana and the country of Italy.