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U.S. Department of Health and Human Services

Class 2 Device Recall Stratus(R) CS Rotors

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  Class 2 Device Recall Stratus(R) CS Rotors see related information
Date Initiated by Firm December 07, 2009
Date Posted November 10, 2010
Recall Status1 Terminated 3 on November 10, 2010
Recall Number Z-0343-2011
Recall Event ID 56976
510(K)Number K984067  
Product Classification Flourometric method, cpk or isoenzymes - Product Code JHX
Product Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09
Intended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratus(R) CS analyzer
Code Information catalog number CROTOR, lot number NH42-251-09
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Siemens Technical Solutions Center
302-631-8467
Manufacturer Reason
for Recall		 Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.
FDA Determined
Cause 2		 Process control
Action The recalling firm, SIEMENS, issued an "Urgent Field Safety Notice" dated December 2009 to all affected customers. The notice described the product, problem and the action to be taken by the customers. The customers were instructed to review the situation with their laboratory director to determine the need to evaluate previously reported test results; immediately examine their CROTOR inventory and discard all bags that are from lot NH42-251-09 including rotors that were not stored in their original packaging (bag); contact Siemens Customer Service Center at 800-241-0420 to request additional no-charge replacements (Note: A "no-charge" order has already been placed so that one bag of replacement rotors would be recieved shortly); forward this notice to anyone they may have distributed this product, and complete and return the FIELD CORRECTION EFFECTIVENESS CHECK via fax at 302-631-8467. If you have any questions regarding this information, please contact the Siemens Technical Solution Center at 800-405-6473.
Quantity in Commerce 330 bags
Distribution Worldwide distribution: USA including states of AK, AZ, AR, CA, FL, GA, HI, IA, IL, IN, KY, LA, MI, MN, MO, MS, MT, NC, ND, NH, NM, NY, OH, TX, UT, WA, WI, and WV and 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 = JHX and Original Applicant = DADE BEHRING, INC.
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