FDA-Device2022-12-28Class II
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
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
3896 kits
Manufactured in
1300 E Touhy Ave, Des Plaines, IL, United States
Products
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0739-2023Don't want to check this manually?
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