Recall Z-0130-2015 ยท DBF Ferritin, Antigen, Antiserum, Control
Siemens Healthcare Diagnostics, Inc
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)
| Date | Oct 24, 2014 (initiated Oct 9, 2012) |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 234 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 Afri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110736 | ADVIA CHEMISTRY FERRITIN (FRT) METHOD Siemens Healthcare Diagnostics, Inc., Aug 17, 2011 |