Recall Z-2410-2012 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
| Date | Sep 19, 2012 (initiated Aug 7, 2012) |
| Status | Terminated |
| Reason | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 |
| Root cause | Nonconforming Material/Component |
| Action | Siemens Healthcare issued an Urgent Field Safety Notice letter dated August 2012 by e-mail to all affected Siemens Healthcare Diagnostics Branch offices on August 7, 2012. Customers were instructed to discontinue using the ADVIA Centaur Calibrator B lots 40 and below following their obtaining Calibrator 8 lot 41 or higher. Customers were asked to complete and fax-back the response form attached. |
| Quantity | 15,445 kits |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904714 | CIBA CORNING ACS PROLACTIN IMMUNOASSAY Ciba Corning Diagnostics Corp., Nov 7, 1990 |