Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests
FDA device recall Z-0162-2013 · posted 2012-10-28 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Reason for recall
- BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
- Action taken
- Siemens sent two "URGENT FIELD SAFETY NOTICE" letters dated August and September 2012 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Form was included for customers to complete and return.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MOI
- Quantity affected
- 15,455 kits
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.
- Date initiated
- 2012-09-11
- Date posted
- 2012-10-28
- Date terminated
- 2016-09-01
- 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 |
|---|---|---|
| CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY (K982680) | Chiron Diagnostics Corp. | 1998-10-15 |