Device product
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.
Z-0214-2015
Product summary
- Event
- Event 69282
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4645 (12 pk)
- Official record key
device-enforcement:Z-0214-2015
Official wording
Reason: Stability of the ADVIA Centaur Cleaning Solution is not assured
Code information: Lot Numbers: 459356 Exp. Date: November 2014; 443105 Exp. Date: November 2014
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.
Derived failure modes
-
Unknown
Stability of the ADVIA Centaur Cleaning Solution is not assured