FDA-Device2014-07-02Class II
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
Siemens Healthcare Diagnostics, Inc
Hazard
Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles
Sold states
Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.
Affected count
3,839 kits
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1927-2014Don't want to check this manually?
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