Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-1812-2018)

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 Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay

Product Classification:

Class II

Date Initiated: March 5, 2018

Date Posted: May 23, 2018

Recall Number: Z-1812-2018

Event ID: 79708

Reason for Recall:

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

Status: Terminated

Product Quantity: 2258

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