Siemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues
Siemens is recalling ADVIA Centaur CA 19-9 Assay kits because they do not meet performance standards on the ADVIA Centaur CP system.
- Product
- ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT in
- Category
- Medical Device
- Distribution
- Distributed nationwide