Various Roche Detection, Amplification Kits and Primary Antibody… — recall 58140
Health Canada — Medical Devices · Canada · 2018-09-17 · Type II
As described by Health Canada — Medical Devices: Various Roche Detection, Amplification Kits and Primary Antibody (2018-08-16)
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Reported risk: Following investigation of customer complaints, the manufacturer confirmed the potential to observe leaking and sticking reagent dispensers that are used on benchmark instruments. This could occur with products intended for greater than 50 actuations and products with emulsifiers. This failure could result in a complete or partial dispense failure of a reagent critical to the staining reaction, potentially leading to erroneous results.
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