Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-1810-2018)

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 Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.

Product Classification:

Class II

Date Initiated: March 5, 2018

Date Posted: May 23, 2018

Recall Number: Z-1810-2018

Event ID: 79708

Reason for Recall:

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

Status: Terminated

Product Quantity: 1485

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