Medical device manufacturer, Abbott Molecular Inc., has issued a Field Safety Notice concerning HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0 (List no: 8L36-03).
According to the manufacturer, internal software development testing identified that when running the HCV-GT II assay, if four or more genotype calls are present for a sample, the software does not generate a result (printed or displayed). Instead a blank field is reported.
This observation will only occur when running:
There have been no reports from customers in regards to this observation.
If you are in possession of the products, please contact your supplier for necessary action.