Device product
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
Z-0129-2015
Product summary
- Event
- Event 69449
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2440 kits
- Official record key
device-enforcement:Z-0129-2015
Official wording
Reason: Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
Code information: Lot numbers: 82069A22 Exp Date: 01/19/2013 82946A22 84494A22 85340A22 85804B22 87430B22 90884B22 95232A23 Exp. Date: 10/16/2013 95589A23 96012A23
Distribution pattern: Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.
Derived failure modes
-
Unknown
Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system