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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description 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.
Recall Number Z-1830-2013
Classification Class II
Code Info 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.
Product Distributed Qty 11,309 bags
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.

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 Letter
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.