SLSolution™

Issue

SLSolution™ reagent includes dithiothreitol (DTT), which is oxidized when it gets in contact with air and/or metals, potentially losing its functionality in fluidification of respiratory specimens. SLSolution™ reagent must show a colourless appearance. On the other hand, when the DTT reagent is deteriorated: the SLSolution™ reagent shows a pink or yellow discoloration (device failure), its functionality in respiratory specimens fluidification cannot be guaranteed. For this reason: SLSolution™ devices are manufactured to guarantee the stability and activity of DTT, a dedicated warning is included in devices' instructions for use (ref. EIFU013, warning number 8) to instruct the user to discard any non-colourless piece ("do not use Copan SLSolution™ if the reagent is not clear/colourless (e.g. pink or yellow)"). Moreover, the device's instructions for use indicate to check whether the specimen is actually suitable for subsequent analysis following treatment with SLSolution™ device (ref. EIFU013, section instructions for use, clause 6: "Homogenize the specimen by vortexing the test tube for at least 3 seconds at 2000-2500 rpm, checking that the specimen is actually suitable for seeding."). the reason for the recall is that in October 2025, following an increase in notifications received from the market on detected yellow/pink devices, related to the period August-September 2025, Copan verified that the occurrence of device failure (pink/yellow discoloration of reagent) of lots already placed on the market of items 0U019N and 0U020N.A may be unexpectedly high. Should the defective devices be used, Copan cannot exclude that the functionality in fluidification of respiratory specimens of defective devices is potentially affected. Hence, in a precautionary manner and considering the unexpectedly high defectivity that may affect marketed lots of items 0U019N and 0U020N.A, Copan is proactively and voluntarily initiating a recall on these devices.