Tosoh Bioscience Inc Recall: Hemoglobin A1c Control, Part no. 220232 for use as quality co
Tosoh Bioscience Inc Recall: Hemoglobin A1c Control, Part no. 220232 for use as quality co is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Tosoh Bioscience Inc; Product: Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory t
| Recalling firm | Tosoh Bioscience Inc |
|---|---|
| Product | Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. |
| 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. |
| Classification | Class III (least serious — unlikely to cause adverse health consequences) |
| Status | Terminated |
| Distribution | Distributed nationwide. Foreign distribution to Canada. |
| Recall initiated | 20181005 |
| Recall number | Z-0601-2019 |
| Category | device |
| State | OH |
| Country | United States |
$29/mo
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