Device product
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
Z-0601-2019
Product summary
- Event
- Event 81188
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1000
- Official record key
device-enforcement:Z-0601-2019
Official wording
Reason: 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.
Code information: Lot 7055
Distribution pattern: Distributed nationwide. Foreign distribution to Canada.
Derived failure modes
-
Unknown
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.