Abbott recalls Alinity ci-series System Control Module units with software versions 3.2.3 and earlier due to potential performance issues including incorrect reagent status displays, damaged connectors, and sample processing errors. Affected units have specific serial numbers and model numbers.
Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.
Abbott is recalling Alinity ci-series System Control Modules with software versions 3.2.3 and earlier because they may display expired reagents as 'OK', cause damaged connectors during maintenance, or lead to incorrect test results. This could affect lab results and equipment safety.
The software issues can cause the system to incorrectly show expired reagents as 'OK', leading to expired reagents being used. Performing certain maintenance procedures may damage connectors, and sample processing errors could result in incorrect test results without proper warnings.
Healthcare labs and clinical testing facilities that use the Alinity ci-series System Control Module with software versions 3.2.3 and earlier are most at risk. Individuals with the affected units should check their serial numbers.
Check if your Alinity ci-series System Control Module has software version 3.2.3 or earlier. Affected units have model number LN 03R70-01 and serial numbers starting with SCM (e.g., SCM01001 to SCM04259).
Verify your software version by checking the device settings or documentation. If it's 3.2.3 or earlier, it's affected.
Reach out to Abbott Laboratories for instructions on how to update the software or return the device if needed.
Software versions 3.2.3 and earlier are affected.
Check if your device has model number LN 03R70-01 and software version 3.2.3 or earlier. Affected units have serial numbers starting with SCM (e.g., SCM01001 to SCM04259).
Contact Abbott Laboratories for instructions on updating the software or returning the device.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2472-2021 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2472-2021 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
