Abbott Molecular, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1518-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

Product Classification:

Class II

Date Initiated: July 19, 2022

Date Posted: August 24, 2022

Recall Number: Z-1518-2022

Event ID: 90651

Reason for Recall:

Incorrect optical calibration

Status: Completed

Product Quantity: 1

Code Information:

Serial Number 00654

Distribution Pattern:

There was only foreign distribution to Italy.

Voluntary or Mandated:

Voluntary: Firm initiated