Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01

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.

On 07/26/2021, the firm sent an "Product Correction Urgent-Immediate Action Required" Notification Letter via FedEx priority overnight express informing customers that the Recalling Firm identified three potential performance issues with software version 3.2.3 and earlier and that the Recalling Firm is releasing software version 3.3.0 to correct the following issues: 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. The processing module transitions into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. Customer are instructed to: 1) Follow the Necessary Actions required in Appendix A until software version 3.3.0 is installed. Appendix A is include with the Notification Letter. 2) A Recalling Firm representative will schedule a mandatory upgrade to software version 3.3.0. 3) If customers have forwarded the affected product to other laboratories, inform them of this Product Correction and provide to them a copy of the Notification Letter. 4) Complete the included Customer Reply Form 5) Retain the Notification Letter with their laboratory records. For questions, U.S. Customers can contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). For Customers outside of the U.S., contact their local area Customer Service.