FDA Enforcement
Class II
Terminated
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
Recall: Z-0130-2015
·
Reported November 5, 2014
Enforcement
- Recall Number
- Z-0130-2015
- Event ID
- 69449
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 5, 2014
- Initiation Date
- October 9, 2012
- Classification Date
- October 24, 2014
- Termination Date
- June 18, 2015
- Address
- 333 Coney St, N/A, East Walpole, MA, 02032-1516, United States
Description
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
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 Info
Lot numbers: 83496A22 88716A22 95040822 95889A22 Exp. 01/19/2013
Distribution
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.
Quantity
234 kits