Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its ARCHITECT EBV VCA IgM Calibrator [List Number: 3P66-01; Lot Number: 08159BE00].
The manufacturer has identified the affected product may show reduced RLU (Relative Light Units) signal. This reduced RLU signal may cause a decrease in cutoff RLU values in assay calibration resulting in:
The effect of decreased cutoff RLU values is observed when using the affected product and is independent from the ARCHITECT EBV VCA IgM reagent lot used. The shift in S/CO values may potentially lead to false grayzone or false reactive patient results when using the affected product. The root cause for this issue is under investigation for an appropriate corrective action.
According to the manufacturer, affected users should immediately discontinue use of, and destroy, any remaining affected products according to their laboratory procedure. In the event the users are currently using or have inventory of the affected lot, they should immediately contact the local supplier for replacement material. Users are advised to review this issue with their Medical Director or Laboratory Management, and follow their laboratory protocol regarding the need for reviewing previously reported patient results.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 3 November 2020