Tosoh Bioscience, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1225-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

Product Classification:

Class II

Date Initiated: November 7, 2016

Date Posted: March 1, 2017

Recall Number: Z-1225-2017

Event ID: 75727

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%.

Status: Terminated

Product Quantity: 682 analyzers

Code Information:

All active analyzers

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,

Voluntary or Mandated:

Voluntary: Firm initiated