Abbott Molecular, FA-AM-NOV2022-283, Alinity m Resp-4-Plex AMP Kit

Abbott has received reports of an increase in reactive negative controls and false positive results, with certain lots of Alinity m Resp-4-PlexAMP Kit (CE), List Number 09N79-090 and of the Alinity m Resp-4-Plex AMP Kit (US), List Number 09N79-096 on the Alinity m System.
Specifically, an increase in the amount of reactive negative controls and false positive results have been reported for the influenza B virus (Flu B) and Respiratory Syncytial Virus (RSV) targets. Based on internal evaluation, false positive results and reactive negative controls manifest as a weak signa} with a late cycle number for these targets. Internal evaluation has not shown impact to influenza A virus (Flu A) and SARS targets.