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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA Centaur Systems HBc Total (HBcT)

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  Class 2 Device Recall Siemens ADVIA Centaur Systems HBc Total (HBcT) see related information
Date Initiated by Firm September 15, 2014
Date Posted October 21, 2014
Recall Status1 Terminated 3 on December 28, 2015
Recall Number Z-0103-2015
Recall Event ID 69292
PMA Number P040004 
Product Classification Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
Product ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use.
Catalog Number: 07566733
Siemens Material Number: 10309508

The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
Code Information Lot Number:  36217064, 36281064, 36449064, 37406064, 38177064  Exp.Date:February 10, 2015
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact Same
508-668-5000
Manufacturer Reason
for Recall		 Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Siemens Healthcare issued An Urgent Medical Device Recall (UMDR) sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 15, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 15, 2014. These notices inform the customer of the imprecision and positive bias and a potential increase in initial reactive results associated with ADVIA Centaur Systems HBc Total Lot 100064. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Each customer will be required to return a completed confirmation fax-back to Siemens.
Quantity in Commerce 5434
Distribution Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and Yemen.
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.
PMA Database PMAs with Product Code = LOM and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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