ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2
FDA device recall Z-2410-2012 · posted 2012-09-19 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Reason for recall
- ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CGJ
- Quantity affected
- 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, Ma
- Date initiated
- 2012-08-07
- Date posted
- 2012-09-19
- Date terminated
- 2014-02-26
- Location
- East Walpole, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CIBA CORNING ACS PROLACTIN IMMUNOASSAY (K904714) | Ciba Corning Diagnostics Corp. | 1990-11-07 |