Tosoh Bioscience Inc recalls Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory test…

Recall date

October 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0601-2019

FDA classification

Class III

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

Distributed nationwide. Foreign distribution to Canada.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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