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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

Product Description G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Recall Number Z-1075-2013
Classification Class III
Code Info 11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R.
Product Distributed Qty 633
Reason For Recall Inspectional observations made during establishment inspection include Quality System Regulation deficiencies found that several undocumented and unreported corrections were made to a device. These corrections may constitute changes to the device that may require the submission of a new 510(k).

Event Detail

Event Id 56584
Product Type Devices
Status Ongoing
Recalling Firm Tosoh Bioscience Inc
City Grove City
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-08-18
Initial Firm Notification of Consignee or Public
Distribution Pattern Worldwide Distribution-USA (nationwide) including DC, Puerto Rico, Virgin Islands and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV, and the countries of Canada, Columbia, Chile, Brazil, and Jamaica.