Class 2 Device Recall SIEMENS ADVIA Centaur CP Immunoassay System BNP kit.

• Date Initiated by Firm: June 23, 2014
• Date Posted: June 26, 2015
• Recall Status: Terminated on March 31, 2016
• Recall Number: Z-2149-2014
• Recall Event ID: 68665
• 510(K)Number: K031038
• Product Classification: Test,natriuretic peptide - Product Code NBC
• Product: 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.
• Code Information: Lot# 38479172 and 39181172
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc; 333 Coney St; East Walpole MA 02032-1516
• For Additional Information Contact: 877-229-3711
• Manufacturer Reason for Recall: Complaints of failed calibration.
• FDA Determined 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 in Commerce: 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. 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NBC and Original Applicant = BAYER HEALTHCARE, LLC