Abbott Molecular, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0462-2022)

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:

Alinity m System, Part No. 08N53-002

Product Classification:

Class II

Date Initiated: December 6, 2021

Date Posted: January 12, 2022

Recall Number: Z-0462-2022

Event ID: 89168

Reason for Recall:

There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.

Status: Ongoing

Product Quantity: 742 devices

Code Information:

Alinity m System, Model 08N53-002, all serial numbers

Distribution Pattern:

Worldwide distribution - US distribution and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated