The Recall Desk
HighFDA (Devices)·Z-0461-2022·Announced 2022-01-12

Alinity m System Software Issue Affects Maintenance and Diagnostics Procedures

Abbott Molecular is recalling 742 Alinity m System units worldwide due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a software defect affecting critical maintenance and diagnostics procedures. No reported illnesses or injuries, but this represents a risk-of-harm product where proper device servicing cannot be completed.

Plain-English summary

Abbott Molecular, Inc. is recalling 742 units of the Alinity m System, Part No. 08N53-002, distributed worldwide across the United States and 43 additional countries. The recall affects all serial numbers of this model.

The recall is due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures on the device. This functional defect could impact the ability to service and diagnose the system.

There are no reported injuries or illnesses associated with this recall. Customers who have received affected units should contact Abbott Molecular for instructions on software remediation.

The recalled product

Product
Alinity m System, Part No. 08N53-002
Manufacturer
Abbott Molecular, Inc.
Category
Medical Device — Diagnostic System
Hazard
  • software-malfunction
  • procedure-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category