Following an investigation of customer complaints, an increase in curve activity and decrease in top point separation between calibrator (CAL) points 5 and 6 was observed for IK018.S lot 472776 (lK018.L.S lot 435251 shares the same components). Cal. 5 OD values may occasionally exceed Cal.6 Values, which may lead to imprecision within this region of the curve. Therefore, TBS will initiate the correction by way of issuing an UFSN to the affected customers. Recall date: 2021-10-14