Recall Z-0601-2019 ยท LCP Assay, Glycosylated Hemoglobin
Tosoh Bioscience Inc
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
| Date | Oct 5, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | The firm sent notification to consignees on October 5, 2018, via Urgent Medical Device Recall letter. The letter informed consignees of the potential degradation of HbA1c control lot 7055 prior to the 60-days product stability claim. Immediate Actions to be taken by the Customer " Review the content of this letter with your laboratory staff. " Inform laboratory staff to avoid storing the control material in direct exposure to light. " Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification. " In the event of an early degra |
| Quantity | 1000 |
| Distribution | Distributed nationwide. Foreign distribution to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021484 | HEMOGLOBIN A1C CONTROL Canterbury Scientific , Ltd., Jun 14, 2002 |