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