Retiro De Equipo (Recall) de VITROS Chemistry Products VANC Reagent. An in vitro diagnostic medical device (IVD).

Recall

RC-2017-RN-00302-1

Class II

2017-03-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00302-1

Ortho clinical diagnostics (ortho) has identified the potential for biased results generated using vitros vanc reagent. this can occur after the reagent packs are loaded onto the analyser and stored within the on-analyser stability date. some customers observed a positive drift of >2 standard deviation (sd) in quality control results when using vitros tdm performance verifiers (levels i, ii & iii). ortho's testing confirmed a positive drift in patient and quality control results within a reagent pack in as few as approximately 7 hours. for the affected lots, results may begin to show a drift as soon as packs are loaded onto the system. the magnitude of positive drift for the affected reagent packs is approximately 8-15% across the vanc reportable measuring range of 5.00–50.00 ìg/ml (3.35–33.50 (ìmol/l).

Users are advised to immediately discontinue using and discard all remaining inventory of VITROS VANC Reagent Packs for the affected lots listed above. Discuss any concerns users may have regarding previously reported results with their Laboratory Medical Director to determine the appropriate course of action. If users do not have an alternate lot in their inventory and have an urgent need to continue testing Vancomycin, they are advised to use the current lot provided that they perform quality control testing with every sample batch (i.e., 1 or more patient samples). Ortho recommends the following: - Run QC fluids prior to and following each sample batch. (Use a minimum of one control fluid at the beginning and end of each sample batch) - Ensure QC results are within acceptable limits prior to releasing sample results until replacement product arrives.