FDA-Device2023-04-12Class II
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Abbott Molecular, Inc.
Hazard
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
Sold states
US Distribution to state of: PA, a government account.
Affected count
1
Manufactured in
1300 E Touhy Ave, Des Plaines, IL, United States
Products
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1349-2023Don't want to check this manually?
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