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Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Recalled April 12, 2023 · FDA recall Z-1349-2023 · Abbott Molecular
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. · FDA Class II
Units
1
Sold at
US Distribution to state of: PA, a government account.
Description
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.
Product
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Manufacturer(s)
Abbott Molecular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →