Abbott Alinity M: Major Adverse Event Report Filed

The customer obtained a falsely elevated alinity c calcium result for multiple patients. the customer uses a normal range of 8. 5 to 10. 5 mg/dl. the following results were provided: On december 09, 2022, abbott molecular issued a field correction recall/urgent field safety notice to all customers who have the alinity m system by fedex priority overnight express. Submitted a product dossier for the alinity m mpxv amp kit and alinity m mpxv ctrl kit in alignment with the u. s. Fda's eua for mpox disease. The alinity m mpxv assay has been designed to minimize the likelihood of false positive test results.

May 19, 2020 · report adverse events, including problems with test performance or results, to medwatch by submitting the online fda form 3500. Jun 28, 2022 · report adverse events, including problems with test performance or results, to medwatch by submitting the online fda form 3500. Alinity m system was under abbott control at an abbott site when it was identified that the sti and hpv positive controls were not reactive. abbott has identified an increase of incidences. Where do i report adverse events? Report adverse events, including problems with test performance or results, to medwatch by submitting the online fda form 3500. Internal studies concluded that the source of cycle number delay can be traced to metal leaching into the lysis solution from the lysis transfer pump in the alinity m system. impact on product.