Recall Z-0129-2015
Siemens Healthcare Diagnostics, Inc · initiated October 9, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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)
Codes / lots: Lot numbers: 82069A22 Exp Date: 01/19/2013 82946A22 84494A22 85340A22 85804B22 87430B22 90884B22 95232A23 Exp. Date: 10/16/2013 95589A23 96012A23
Reason for recall
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
FDA-determined cause: Nonconforming Material/Component
Action taken
Siemens issued an Urgent Field Safety Notice via e-mail to all US customers affected on October 9, 2012. This notice informs the customer of the Field Correction and the actions that need to be taken. The Urgent Field Safety Notice instructs customers that upon receipt of Calibrator C Lots ending in 25 and higher (Cal C lots CC25LA and higher and Cal C lots CC25HA and higher), discontinue use of the Calibrator C lots ending in 22 and 23 with the ADVIA Centaur Ferritin assay when used on the ADVIA Centaur CP system. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Further questions please call (508) 668-5000
Details
- Recall number
- Z-0129-2015
- Initiated
- October 9, 2012
- Posted by FDA
- October 24, 2014
- Terminated
- June 18, 2015
- Product code
- DBF – Ferritin, Antigen, Antiserum, Control
- Quantity
- 2440 kits
- 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0128-2015 Class II | ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the…Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the… | 10/09/2012Terminated |
| Z-0130-2015 Class II | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA…Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the… | 10/09/2012Terminated |