ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Dia
FDA device recall Z-0129-2015 · posted 2014-10-24 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- 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
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DBF
- Quantity affected
- 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, M
- Date initiated
- 2012-10-09
- Date posted
- 2014-10-24
- Date terminated
- 2015-06-18
- Location
- East Walpole, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVIA CHEMISTRY FERRITIN (FRT) METHOD (K110736) | Siemens Healthcare Diagnostics, Inc. | 2011-08-17 |