Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
This recall has been terminated (originally issued November 7, 2016).
- Company
- Tosoh Bioscience, Inc.
- Recall Initiated
- November 7, 2016
- Terminated
- February 9, 2021
- Recall Number
- Z-1225-2017
- Quantity
- 682 analyzers
- Firm Location
- South San Francisco, CA
- Official Source
- View on FDA website ↗
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%.
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,
Lot / Code Info
All active analyzers
Root Cause
Software design
Action Taken
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.