Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Access 25(OH) Vitamin D Total for use on Access 2 and Dxl [Reference: B24838, A98856; All Lots; Multiple expiry dates].
The manufacturer reported that the Access Vitamin D assay protocol files (APF) contain an incorrect molecular weight, of which its system software uses this value to convert mass (i.e. ng/mL) to molar units (i.e. nmol/L).
According to the manufacturer, this incorrect molecular weight value only impacts Access Vitamin D test results if the system software converts them from mass units to molar units. Access Vitamin D results reported in mass units are not impacted by this issue. However, Access Vitamin D test results that are reported in molar units will be 3.685% higher than expected. This increase is not clinically significant.
The manufacturer does not recommend a retrospective review of Vitamin D test results. The manufacturer is instructing affected users to install the new version of APF to resolve this issue.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 20 April 2021