Agency classClass IIOur severity:High FDA (Devices)·Z-2472-2021·Announced 2021-09-22

Alinity ci-series System Control Module Software Performance Issues

Abbott's Alinity ci-series analyzers with software version 3.2.3 and earlier have multiple issues that could display expired reagents as valid, fail to alert operators to errors, and produce incorrect test results.

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 a FDA Class II recall for a diagnostic device with potential to produce incorrect test results that could affect patient care. No illnesses or injuries have been reported, and the issues are theoretical or potential in nature.

Plain-English summary

The Alinity ci-series System Control Module is a clinical chemistry and immunoassay analyzer used in medical laboratories for in vitro diagnostic testing. Abbott Laboratories has recalled 4,833 systems due to software performance issues in version 3.2.3 and earlier, with worldwide distribution.

The software issues include: expired reagents may be incorrectly displayed with an "OK" status on the Reagent Status screen, allowing expired materials to remain in the carousel for sample processing; sample processing errors may occur without alerting the operator of a reagent pipettor failure, potentially allowing tests to proceed without proper reagent dispensing and produce incorrect results; reagent and sample manager indicators may blink green incorrectly, signaling processing is complete when access should be prevented; insufficient reagent dispense amounts are possible; and erroneous calibration curves may be generated. Performing monthly maintenance procedure 5701 may also cause connector damage or leaking connections.

These issues have the potential to produce incorrect diagnostic test results. The recall affects systems with model number LN 03R70-01 running software version 3.2.3 and earlier. This is classified as a Class II recall by the FDA.

The recalled product

Product: Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Manufacturer: Abbott Laboratories
Category: Medical Device — Clinical Chemistry Analyzer
Hazard: incorrect-test-results
expired-reagent-usage
equipment-malfunction
software-performance-failure
Affected units: 4,833

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 (20)

SCM01002
SCM01003
SCM01004
SCM01005
SCM01006
SCM01007
SCM01008
SCM01009
SCM01010
SCM01011
SCM01012
SCM01013
SCM01014
SCM01015
SCM01016
SCM01017
SCM01018
SCM01019
SCM01020
SCM01021

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Abbott Laboratories

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