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Recall Observatory FDA recall evidence

Device product

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

June 02, 2014

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 68537
Status
Terminated
Classification
Class II
Quantity
3,839 kits
Official record key
device-enforcement:Z-1927-2014

Official wording

Reason: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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