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.
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: 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
- Hazard
- incorrect-test-results
- expired-reagent-usage
- equipment-malfunction
- software-performance-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 (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.
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