Abbott Molecular, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1349-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 11, 2022

Date Posted: April 12, 2023

Recall Number: Z-1349-2023

Event ID: 91777

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.

Status: Ongoing

Product Quantity: 1

Code Information:

Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.

Distribution Pattern:

US Distribution to state of: PA, a government account.

Voluntary or Mandated:

Voluntary: Firm initiated