Patient sid; (b)(6).All available patient information was included, no additional patient information was available.During the investigation, it was determined that the results were impacted by an error associated with the reagent probe (r1) wash cycle, which was introduced in the alinity s system software version 2.8.0, ln 04u76-15.The wash cycle removes fluid that remains on the interior and exterior surfaces of the probes at the wash station.With this error, the r1 probe washing is utilizing 1 ml versus the intended 3 ml of wash buffer to wash the exterior of the r1 probe.With this error, while operating on the alinity s system software version 2.8.0, ln 04u76-15, there is a potential for (b)(6) alinity s (b)(6) combo test results when alinity s (b)(6) combo reagent kit, ln 06p0155, and the alinity s (b)(6) reagent kit, ln 04w5655, are calibrated and run on the same processing lane.Abbott issued product correction letters to all customers who have an alinity s system installed.Customers who do not have alinity s (b)(6) assay commercially available have also been made aware of software issue.The letter states there have been no reports of (b)(6) results associated with this event for the assays available to them, and there is no potential for incorrect (b)(6) results.The letter also informs them that a future software update will correct the issue.Note: the alinity s (b)(6) reagent kit is not currently available in the united states.
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