FDA recall Z-0740-2023

Abbott Molecular, Inc. · Class II · device

Product

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090

Reason for recall

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

Distribution

Worldwide

Key facts

Status: Ongoing
Initiation date: 2022-11-22
Report date: 2022-12-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Des Plaines, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0740-2023