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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65147

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

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Event summary

Timeline bucket
May 10, 2013
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(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.

Z-0433-2014
Recall number
Z-0433-2014
Initiated
May 10, 2013
Classification
Class II
Status
Terminated
Quantity
262

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.

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

Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.

Code information

Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)

Distribution pattern

Worldwide Distribution: USA (nationwide) and internationally to Canada.