Abbott Laboratories: Alinity ci-series System Software Recalled for Performance and Report Errors

Agency Publication Date: December 22, 2023

Summary

Abbott Laboratories is recalling 8,424 units of the Alinity ci-series System Control Module due to multiple software defects in versions 3.4.0 and lower. These defects include errors in reagent loading, laboratory reporting, and assay information processing, which can lead to incorrect diagnostic results for various medical tests. The issue also involves physical defects such as labels not sticking to reagent bottles and hardware modules failing to expire after their warranty period.

Risk

The software and hardware issues can cause the system to produce erroneous patient test results for multiple analytes, which could lead to incorrect medical diagnoses or delayed treatments. No specific patient injuries have been reported in the data, but the potential for diagnostic error across thousands of systems represents a significant clinical risk.

What You Should Do

Identify your system by checking the control module for Model/REF number 03R70-01 and verify if your software version is 3.4.0 or lower.
Check the ICT Module hardware to ensure it is operating within warranty, and inspect reagent bottles for any loose or peeling User-Applied Labels.
Review the Sample Laboratory Reports and assay information downloads for any identified processing errors described in the manufacturer notification.
Contact your healthcare provider or Abbott Laboratories directly at the address 1915 Hurd Dr, Irving, Texas, 75038 to discuss software updates or corrective actions for your specific system.
For additional information or to report performance issues, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Software update and manufacturer guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Alinity ci-series System Control Module, REF: 03R70-01

Model / REF:

03R70-01

UPC Codes:

00380740137410

Lot Numbers:

Software Version 3.4.0 and lower

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93483

Status: Active

Manufacturer: Abbott Laboratories

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 8,424

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify your system by checking the control module for Model/REF number 03R70-01 and verify if your software version is 3.4.0 or lower.

Check the ICT Module hardware to ensure it is operating within warranty, and inspect reagent bottles for any loose or peeling User-Applied Labels.

Review the Sample Laboratory Reports and assay information downloads for any identified processing errors described in the manufacturer notification.

Contact your healthcare provider or Abbott Laboratories directly at the address 1915 Hurd Dr, Irving, Texas, 75038 to discuss software updates or corrective actions for your specific system.

For additional information or to report performance issues, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.