Abbott Molecular, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1009-2023)

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:

Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.

Product Classification:

Class II

Date Initiated: December 9, 2022

Date Posted: February 1, 2023

Recall Number: Z-1009-2023

Event ID: 91286

Reason for Recall:

The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.

Status: Ongoing

Product Quantity: 918 units

Code Information:

Model Number: 08N53-002

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated