Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-1809-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.

Product Classification:

Class II

Date Initiated: March 5, 2018

Date Posted: May 23, 2018

Recall Number: Z-1809-2018

Event ID: 79708

Reason for Recall:

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

Status: Terminated

Product Quantity: 6049

Code Information:

All lots.

Distribution Pattern:

USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

Voluntary or Mandated:

Voluntary: Firm initiated