Recall Z-2149-2014 ยท NBC Test, Natriuretic Peptide
Siemens Healthcare Diagnostics, Inc
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
| Date | Jun 26, 2015 (initiated Jun 23, 2014) |
| Status | Terminated |
| Reason | Complaints of failed calibration. |
| Root cause | Other |
| Action | Siemens sent an Urgent Medical Device Correction (UMDC) letter to all affected Siemens Healthcare Diagnostics customers in the United States on June 23, 2014 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on June 23, 2014 via hard copy, email, and/or fax per each country's local regulations. These notices inform the customer of the potential for low calibrator deviation failures when using ADVIA Centaur Systems BNP kit lots ending in 172 on the ADVIA Centaur CP due to an error on the master curve card. Siemens |
| Quantity | 1,191 kits |
| Distribution | Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada, Albania, Argentina, Australia, Bosnia Herzeg., Brazil, Chile, Colombia, Egypt, Georgia, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Japan, Kazakhstan, Lebanon, Malaysia, New Caledonia, Oman, P.R. Chin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031038 | ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY Bayer Healthcare, LLC, Jun 23, 2003 |