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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67603

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

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Event summary

Timeline bucket
February 18, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics

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

ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.

Z-1553-2014
Recall number
Z-1553-2014
Initiated
February 18, 2014
Classification
Class II
Status
Terminated
Quantity
5,900 units total (1,679 domestically & 4,221 internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.

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

Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.

Code information

All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb.

Distribution pattern

Nationwide and internationally