Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68394

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
Siemens Healthcare Diagnostics, 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

syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.

Z-1944-2014
Recall number
Z-1944-2014
Initiated
May 20, 2014
Classification
Class II
Status
Terminated
Quantity
336

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.

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

Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.

Code information

syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B

Distribution pattern

Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.