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

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.

Details from the source

Reason for recall: 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. Distribution: US Distribution to state of: PA, a government account. Quantity: 1 Lot/code info: Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.

UPC codes

00884999048034

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.