Tosoh—​Hemoglobin A1c Controls: May Degrade before Claimed 60-Day Product Stability

November 28, 2018 | Strategic Insights for Health System


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In an October 5, 2018, Urgent Medical Device Recall Correction letter submitted by an ECRI Institute member hospital, Tosoh states that although HbA1c levels 1 and 2 have a stability claim of 60 days for opened vials, degradation may still occur, potentially resulting in P00 peaks and the % HbA1c control values drifting higher than the assigned range. Tosoh also states that this problem can be recognized when reviewing the chromatograms and the calculated % HbA1c value. If degradation of the control lot occurs, this may result in delays when performing routine instrument quality control (QC), potentially leading to delays in testing and reporting patient test results. Tosoh has received two reports of this problem occurring; however, it has received no reports of serious injuries related to this problem. Tosoh further states that this problem occurs because of improper storage. The manufacturer has not confirmed the...

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