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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65576
Product Type Devices
Status Ongoing
Recalling Firm Tosoh Smd Inc
City Grove City
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-15
Initial Firm Notification of
Consignee or Public
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II 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. 11,309 bags Z-1830-2013