medical Class II Updated 2023-04-12

Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplifica

Recalled Product

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

Hazard / Issue

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.

Issued by

FDA

Affected States: PA
Lot/Code Info: Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.
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