FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 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.
- Recall number
- Z-2150-2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 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.
- Status
- Terminated
- Initiated
- 2014-06-23
- Posted
- 2015-06-26
- Terminated
- 2016-03-31
- 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 informs customers if a successful calibration is achieved, the results obtained are valid. If customers are unable to obtain a successful calibration on the ADVIA Centaur CP, they should switch to an alternative lot of BNP assay. The notices should be reviewed with the facility's laboratory or medical director. Fax-back forms will be used to confirm that the customers received the UMDC. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Correction and completed the required actions. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 877-229-3711.
- Quantity
- 961 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. China, Pakistan, Philippines, Qatar, Rep. of Yemen, Republic Korea, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, Taiwan, Thailand, U.A.E., Ukraine, Venezuela, Vietnam, Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- Lot, serial or model codes
- Lot# 38059172 and 39463172
- 510(k) numbers
- ["K031038"]
- PMA numbers
- not on file
- Product code
- NBC
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28