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U.S. Department of Health and Human Services

Class 3 Device Recall ADVIA Centaur BNA Assay

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  Class 3 Device Recall ADVIA Centaur BNA Assay see related information
Date Initiated by Firm October 06, 2014
Date Posted November 19, 2014
Recall Status1 Terminated 3 on July 22, 2015
Recall Number Z-0229-2015
Recall Event ID 69461
510(K)Number K031038  
Product Classification Test,natriuretic peptide - Product Code NBC
Product ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers:
Cat No. 02816138/SMN 10309044 (100 test)
02816634/SMN 10309045 (500 test)
Code Information Lot 038174: 100 Test - 43305174 and 43278174; 500 Test - 43306174 and 43279174.
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		 Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.
FDA Determined
Cause 2		 Labeling mix-ups
Action A Customer Notification (CN) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on October 03, 2014 to be delivered to customers on October 06, 2014 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 06, 2014. These notices inform the customer of the potential to receive an ADVIA Centaur BNP ReadyPack with a FT4 human-readable side label. Siemens instructs customers to inspect their inventory and discard any BNP Readypacks with a FT4 side label. In addition, Siemens informs customers the end labels of the affected ReadyPacks correctly identify the pack as BNP and Siemens has confirmed the reagent within these packs is BNP Reagent. Therefore valid BNP results will be generated when calibrating and running quality control or patient samples. Fax-back forms will be used to confirm that the customers received the notification. 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 Customer Notification and completed the required actions.
Quantity in Commerce 100 test - 4,600 kits; 500 test - 1,878 kits
Distribution Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Greece, Guadeloupe, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Reunion, Russian Fed., Slovakia, Slovenia, Spain, Switzerland, Turkey, Unit.Arab Emir., AR, AU, BR, CL, CN, CR, IN, JP, KR, LK, MY, SG, TW, UY, VN, and ZA.
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
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