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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur CA 125 II

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  Class 2 Device Recall ADVIA Centaur CA 125 II see related information
Date Initiated by Firm December 14, 2010
Date Posted March 02, 2011
Recall Status1 Terminated 3 on April 12, 2013
Recall Number Z-1477-2011
Recall Event ID 57427
510(K)Number K020828  
Product Classification in vitro diagnostic - Product Code LTK
Product ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows:
Product code: 09427226 (128532) 100 test kit
Product code: 01678114 (128533) 500 Test kit
Code Information Lot Code: 144 Affected kit lot numbers: 62431144, 63124144, 63519144, 63876144, 62450144 and 63822144 Expiry Date: 15 September 2011
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
508-359-3825
Manufacturer Reason
for Recall		 Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal
FDA Determined
Cause 2		 Process control
Action Siemens Healthcare Diagnostics on 12 /14/10 issued Urgent Device Recall notice via Federal Express to accounts. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Device Recall notice directs customers to immediately discontinue the use of ADVIA Centaur CA 125 II assay kits that contain CA 125 II reagent lot 144. It also recommends that patient results obtained with this reagent lot be reviewed. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Technical questions, please contact the Technical Solutions Center at 1-877-229-3711
Quantity in Commerce 2960 units
Distribution Worldwide distribution, including USA, Canada, Argentina, Austria, Belgium, China, Denmark, France, Germany, Great Britain, Greece, India, Italy, Japan, Korea, Lavitia, Lithuania, Malyasia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Switzerland, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Czech Republic, Taiwan, Turkey, Uganda, and Venezuela
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 = LTK and Original Applicant = BAYER CORP.
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