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U.S. Department of Health and Human Services

Class 3 Device Recall ADVIA Centaur Calibrator A

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  Class 3 Device Recall ADVIA Centaur Calibrator A see related information
Date Initiated by Firm June 28, 2013
Date Posted August 14, 2013
Recall Status1 Terminated 3 on July 25, 2014
Recall Number Z-1970-2013
Recall Event ID 65626
510(K)Number K961510  
Product Classification Calibrator, primary - Product Code JIS
Product ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF).


For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
Code Information REF 10285904 (6 pack): 89983A77 16 Jul 2013, 90669A77 16 Jul 2013; REF 10285905 (6 pack - REF); 90705A77 16 Jul 2013
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
508-660-4567
Manufacturer Reason
for Recall		 Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Medical Device Correction (UDMC) was sent to all affected Siemens Healthcare Diagnostic customers in the United States on June 28, 2013 via FedEx. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on June 27, 2013. FedEx Return Receipts will be used to confirm that the customers received the UMDC. If confirmation of receipt by any customer cannot be verified through a return receipt, a Siemens Technical Solutions Center Representative will contact those customers by telephone to ensure that they received the Urgent Medical Device Correction and completed the required actions. These notices inform the customer that they should discontinue the use of Calibrator A, lots ending in 77, for use with the ADVIA Centaur Systems T4 assay. Customers are informed that they may continue to use Calibrator A lot CA77 with the other assays FT3, FT4, Total T3, T-Uptake. For questions or additional information contact your local Technical Support Provider or Distributor.
Quantity in Commerce 265 Cal A 6 packs (US and OUS)
Distribution Worldwide Distribution-Nationwide including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, VA, VT, and WV and the countries of Slovakia, Germany, Turkey, TW, HK, CH, TH, BR, CN, SG, 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 = JIS and Original Applicant = CIBA CORNING DIAGNOSTICS CORP.
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