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Tosoh Bioscience Inc recalls Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testi
Recalled December 19, 2018 · FDA recall Z-0601-2019 · Tosoh Bioscience
Hazard
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. · FDA Class III
Units
1000
Sold at
Distributed nationwide. Foreign distribution to Canada.
Description
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.
Product
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
Manufacturer(s)
Tosoh Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →