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U.S. Department of Health and Human Services

Class 2 Device Recall Tosoh Bioscience HLC723G8 Analyzer

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  Class 2 Device Recall Tosoh Bioscience HLC723G8 Analyzer see related information
Date Initiated by Firm November 07, 2016
Create Date February 17, 2017
Recall Status1 Terminated 3 on February 09, 2021
Recall Number Z-1225-2017
Recall Event ID 75727
510(K)Number K131580  K071132  
Product Classification Control, hemoglobin, abnormal - Product Code JCM
Product Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Code Information All active analyzers
Recalling Firm/
Manufacturer		 Tosoh Bioscience, Inc.
6000 Shoreline Ct Ste 101
South San Francisco CA 94080-7606
For Additional Information Contact Susan H. Koss
614-317-1909
Manufacturer Reason
for Recall		 The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.
FDA Determined
Cause 2		 Software design
Action Recall notification letters were distributed to customers on 11/7/16. The letters instructed customers to review the chormatography to determine whether or not a variant peak was detected. If so, restest the sample using an alternative method.
Quantity in Commerce 682 analyzers
Distribution Worldwide distribution. The products were shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, AND WY. The recalled products were shipped to the following countries: Brazil, Chile, Columbia, Guatemala, Costa Rica, Dominican Republic, Eduador, Nicaragua, Panama, Peru, Puerto Rico, 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 = JCM and Original Applicant = Tosoh BioScience, Inc.
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