Customers have experienced false positive results while testing patient samples using a cf inplex asr card.This product is an analyte specific reagent.The customer initially received het positive results (s549r a>c) for the impacted samples, but after re-extracting and re-testing the samples, the customer received normal/wt results.The incorrect results were experienced in lane eight of the impacted cards.There is no impact to patient results since the customer did not report incorrect results.Hologic is in the process of voluntarily recalling this product.Lot number u35 includes sublots u34ed, u34ej, u34em, u34eo, u34en, u34es, u34el and u34er.
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