Medical device manufacturer, Biomérieux, has issued a medical device safety alert concerning its ARGENE reagents. The following products with the reference numbers are affected by this issue described below:-
Product name (Reference number): ADENOVIRUS R-gene KIT (69-010B); EBV R-gene (69-002B; BK VIRUS R-gene KIT (69-013B); CMV R-gene (69-003B); HSV1 HSV2 VZV R-gene KIT (69-004B); CMV HHV6,7,8 R-gene (69-100B); QUANTI FIuA QS r-gene (68-006); Parvovirus B19 R-GENE (69-019B); QUANTI HHV8 QS r-gene (68-008); Enterovirus R-gene (69-005B); HHV6 Premix r-gene (69-100R6); Bordetella parapertussis r-gene (71-012); HHV7 Premix r-gene (69-100R7); Influenza A/B r-gene (71-040); HHV8 Premix r-gene (69-100R8) ; RSV/hMPV r-gene (71-041) ; CELL Control r-gene (71-106) ; Rhino&EV/Cc r-gene (71-042) ; PARECHOVIRUS r-gene (71-020) ; AdV/hBoV r-gene (71-043) ; HCoV/PIV r-gene (71-045) ; Chla/Myco pneumo r-gene (71-044) ; HSV1 r-gene (71-015); Legio pneumo/Cc r-gene (71-046) ; HSV2 r-gene (71-016) ; FLU A(M) & H1NI 2009 r-gene (71-300) ; VZV r-gene (71-017); Bordetella R-gene ( 69-011B)
The use of the ARGENE reagents on RotorGene system was validated during reagent development using the RotorGene consumable "Strips 4 tubes". This specification on Rotor-Gene consumable associated with ARGENE reagent performance has not been specified in ARGENE reagents' Instruction for Use.
Following a customer complaint and an internal investigation, the manufacturer has been confirmed that an interaction between the other RotorGene disposables could cause validation issues. For the tests including HSV2 parameter, the test's sensibility is reduced due to the interaction with the consumable causing low positive results to shift to (false) negative.
According to the manufacturer, there is a potential risk to cause delayed results considering the incompatibility between the reagents and the consumable appears immediately and could lead to invalid results. The ability to obtain a false result associated to a valid run has been estimated as remote.
The manufacturer requests the user to validate the use of the other consumables than Strips 4 tubes in their applications, in case they would like to continue using them on the Rotor-Gene system in conjunction with ARGENER reagents.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 May 2016