Agency classClass IIOur severity:High FDA (Devices)·Z-0613-2024·Announced 2024-01-03

Alinity ci-series System Control Module Software Performance Issues Recalled

Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is potential—software defects that could produce erroneous test results. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the maximum score is 3.

Plain-English summary

Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units (REF: 03R70-01) that operate under software versions 3.4.0 and lower. The Alinity ci-series is a laboratory automation system used for patient testing and diagnostics.

The software contains performance issues that could lead to erroneous test results. These issues include reagent load errors during daily maintenance, sample laboratory report errors, missing user-error prevention in calibrator lot creation, test processing failures after system errors, incorrect validation of sample dilution volumes, user-applied label adhesion problems, and warranty expiration tracking errors for the ICT Module.

The affected units have been distributed throughout the United States, Puerto Rico, and numerous countries worldwide, including Canada, Australia, Japan, and countries throughout Europe, Asia, Africa, and Latin America.

Users of affected systems should contact Abbott Laboratories regarding available corrections for the identified software issues. Facility administrators should verify their systems are operating under corrected software versions.

The recalled product

Product: Alinity ci-series System Control Module, REF: 03R70-01
Manufacturer: Abbott Laboratories
Category: Medical Device — Laboratory Automation System
Hazard: software-defect
erroneous-results
reagent-error
Affected units: 8,424

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 (1)

UDI-DI: 00380740137410. Software Version 3.4.0 and lower.

Distribution

Distributed in 46 states:

Same manufacturer · Abbott Laboratories

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