Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
FDA Recall Z-1225-2017 · Posted None
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Recalling FirmTosoh Bioscience, Inc.
Recall StatusTerminated
Product CodeJCM
Date Initiated2016-11-07
Date Terminated2021-02-09
Product Quantity682 analyzers
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%.
Firm 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.
Root Cause
Software design
Distribution Pattern
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,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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