Retiro De Equipo (Recall) de Monolisa HCV Ag-Ab ULTRA V2 assay. An in vitro diagnostic medical device (IVD)

Recall

RC-2017-RN-00444-1

Class II

2017-04-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00444-1

Bio-rad laboratories have noticed a decrease of all optical densities (od) values for tested samples and controls. this could result in plate invalidation. specific lots are affected by this phenomenon which causes a global decrease of all od values appears some months after the manufacturing release of the lots. the reconstituted antigen positive control - r5 is more impacted by the decrease of od values and results in run invalidation when its od becomes lower than 0.5. however, since final results (ratios) are not impacted, there is no risk of an erroneous result.

Users are asked to; · To continue to use kits and lots in table 1 as long as the validation criteria are met (refer to product package insert (section 7.5) for detailed instructions): 1) For the negative control R3: O.D. < cut off x 0.6 2) For the antibodies positive control R4: 0.800 = Mean O.D. = 2.700 3) For the working solution R5: O.D. > 0.500 · To stop using kits of lots in table 1 if validation criteria failed. In that case, discard the kit, fill the Annex 1 Customer Response Form and return it to your customer service to obtain replacement kits.