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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68537

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

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Event summary

Timeline bucket
June 02, 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

Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments

Z-1927-2014
Recall number
Z-1927-2014
Initiated
June 02, 2014
Classification
Class II
Status
Terminated
Quantity
3,839 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles

Code information

Kit Lot Number: 454779 Exp. Date: 28 February, 2015

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.