Recall Z-0128-2015

Siemens Healthcare Diagnostics, Inc · initiated October 9, 2012

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)

Codes / lots: Lot numbers: 82052A22 Exp Date 01/19/2013 82335A22 82909A22 85268A22 86701B22 88921B22 89956B22 90925B22 91336B22 95231A23 Exp. Date: 01/16/2013 95553A23

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-0128-2015
Initiated
October 9, 2012
Posted by FDA
October 24, 2014
Terminated
June 18, 2015
Product code
DBF – Ferritin, Antigen, Antiserum, Control
Quantity
8263 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

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0129-2015 Class IIADVIA 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
Z-0130-2015 Class IIADVIA 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