Recall Z-1225-2017 ยท JCM Control, Hemoglobin, Abnormal
Tosoh Bioscience, Inc.
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
| Date | Nov 7, 2016 |
| Status | Terminated |
| Reason | 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%. |
| Root cause | 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 | 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 s |
| FDA record | Open on fda.gov |