Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplifica
See all recalls from Abbott Molecular, Inc. →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.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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