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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67030

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

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Event summary

Timeline bucket
December 17, 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

Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.

Z-0800-2014
Recall number
Z-0800-2014
Initiated
December 17, 2013
Classification
Class II
Status
Terminated
Quantity
1563

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.

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

An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.

Code information

ADVIA 1200 with software versions: V2.00 and V2.01 ADVIA 1650 with software versions V3.52 and V4.01

Distribution pattern

Worldwide Distribution. USA nationwide and the country of Canada.