Breaking News: Alinity M System Adverse Event Report

Adverse reactions or quality problems experienced with the use of this product may be reported to the fda’s medwatch adverse event reporting program online. Abbott has identified four potential performance issues for the alinity m system software and will release an updated alinity m system software version to correct these issues (see details in. The customer reported liquid leak in the system solutions drawer of the alinity m system. the leak from liquid waste had reached the floor and went beyond the footprint on the.

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Dec 23, 2022 · abbott has identified three potential issues which may have impacted the amplification detection unit(s) (adu) installed on your alinity m system. Jun 28, 2022 · report adverse events, including problems with test performance or results, to medwatch by submitting the online fda form 3500. An issue has been identified regarding the led_ref_diff values on the amplification detection modules (adu). There is potential that there are incorrect led_ref_diff values installed on some.

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This issue has been observed with. The manufacturer is grouping instrument related issues which have the potential for incorrect results on the alinity m system. 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.

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