The customer reported false positive reactions with erytype s abd+rev.A1, b when used on tango optimo.The customer stated that reactions were not resuspended on tango optimo and therefore interpreted as being positive.The customer returned neither the supposedly defective product nor the specimens that had caused false positive reactions.Therefore our quality control laboratory tested their retention sample of erytype s abd+rev.A1, b with different red blood cells on tango optimo.All positive and negative reactions were correct.All negative reactions were completely resuspended.We did not observe any false positive reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of erytype s abd+rev.A1, b functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected tango optimo was inspected by our field service engineers and the orbital shaker's was found to be in need of repair.The right needle adapter's cable was damaged, bubbles were found inside the right syringe and scratches on the right needle.The right syringe, right needle adapter and right needle were replaced.After this intervention, a qc was run and all results were as expected.The system performance was validated and found to be within manufactures specification.The instrument related complaint will be closed as confirmed, because change of defective and affected parts by bubbles and scratches (single event) resolved the issue.The tango optimo was confirmed to operate in specification by our field service engineers upon service intervention.
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