FDAFDA · Food and drugs·Recall number Z-1927-2014
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
Published July 2, 2014 · Recall initiated: June 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Distributor
- Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.
- Lot
- Kit Lot Number: 454779 Exp. Date: 28 February, 2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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