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U.S. Department of Health and Human Services

Class 2 Device Recall Dade(R) Actin(R) FSL Activated PTT Reagent

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  Class 2 Device Recall Dade(R) Actin(R) FSL Activated PTT Reagent see related information
Date Initiated by Firm March 11, 2013
Date Posted April 09, 2013
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-1073-2013
Recall Event ID 63804
510(K)Number K863594  
Product Classification Test, time, partial thromboplastin - Product Code GGW
Product Dade(R) Actin(R) FSL Activated PTT Reagent.

For use in the determination of the activated partial thromboplastin time (APTT).
Code Information Catalog numbers B4219-1 and B4219-2: lot numbers 547311, exp 3/22/2013; 547312, exp 3/22/2013 and 547316A, exp 4/28/2013.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
302-631-6311
Manufacturer Reason
for Recall		 Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Siemens sent an "URGENT FIELD SAFETY NOTICE" dated February 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The safety notice instructed consignees to discontinue use of the affected lots and discard any remaining inventory. Contact the firm at 1-800-242-3233, option 1 for questions about this notice.
Quantity in Commerce 13,083
Distribution Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Puerto Rico and the country of Canada.
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 = GGW and Original Applicant = AMERICAN DADE
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