Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-0601-2019)

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:

Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.

Product Classification:

Class III

Date Initiated: October 5, 2018

Date Posted: December 19, 2018

Recall Number: Z-0601-2019

Event ID: 81188

Reason for Recall:

Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.

Status: Terminated

Product Quantity: 1000

Code Information:

Lot 7055

Distribution Pattern:

Distributed nationwide. Foreign distribution to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated