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:

• m2000rt Instrument System Software v4.0 and v5.0 AND
• HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0.

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.