FDA-Device2022-12-28Class II
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Abbott Molecular, Inc.
Hazard
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Sold states
Worldwide
Affected count
12116 kits
Manufactured in
1300 E Touhy Ave, Des Plaines, IL, United States
Products
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0740-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief