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U.S. Department of Health and Human Services

Class 2 Device Recall AIA Analyzer Pipette Tips

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  Class 2 Device Recall AIA Analyzer Pipette Tips see related information
Date Initiated by Firm May 15, 2013
Date Posted July 30, 2013
Recall Status1 Terminated 3 on November 27, 2013
Recall Number Z-1830-2013
Recall Event ID 65576
510(K)Number K971103  
Product Classification Fluorometer, for clinical use - Product Code KHO
Product AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag

AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
Code Information The following lots numbers are affected by this recall:   060811, 070111, B11, B11-12/23/2011, B12-02/07/2012, B12-04/30/2012, B12-06/01/2012, B12-08/06/2012, B12-09/05/2012, B12-10/26/2012, and B12-11/27/2012.
Recalling Firm/
Manufacturer		 Tosoh Smd Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact Susan (NMI) Koss
614-317-1909
Manufacturer Reason
for Recall		 Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Tosoh Bioscience sent an Urgent Recall Notification letter dated May 15, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to respond on the amount of product that was destroyed by completing the attached form and faxing it to 614-317-1941. Customers with questions were instructed to call Tosoh Technical Support at 1-800-248-6764. For questions regarding this recall call 614-317-1909.
Quantity in Commerce 11,309 bags
Distribution Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Internationally to Canada, Japan, Mexico, Chile, and Uruguay.
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 = KHO and Original Applicant = TOSOH MEDICS, INC.
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