MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY CI-SERIES SYSTEM CONTROL MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R70-01
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed erratic qc results and noticed salt buildup on the induction heating element.The issue occurred on the alinity ci-series scm module, serial number (b)(6).The incubation heater was cleaned from salt build up and sample syringe was replaced.There was no impact to patient management or user safety was reported.
Additional Manufacturer Narrative
Investigation into this issue found this incident was impacted by an issue identified in alinity ci system software 3.6.1 and lower where inadequate alinity i-series maintenance procedures can result in salt buildup on the induction heater (ih) assembly which can reduce sample pipettor wash performance, increasing the risk of sample carryover.The issue has the potential to generate incorrect results.A product correction letter was issued on 13nov2025 to all alinity customers who have installed alinity i processing modules, notifying them of the issue.The product correction letter also provides the necessary steps to take if the potential issue is observed until they receive the mandatory upgrade of alinity ci-series system software version 3.7.0.Abbott is releasing alinity ci software version 3.7.0 to correct the issue and enhance the overall system.Root cause investigation is ongoing, and the outcome of the investigation will be communicated through rcr# 3016438761-11192025/c/1.

• Brand Name: ALINITY CI-SERIES SYSTEM CONTROL MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23966362
• Report Number: 3016438761-2026-00007
• Device Sequence Number: 4810491
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K230790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03R70-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3016438761-11192025/C/1
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNT CI SW V3.6.0, 04V20-27, UNKNOWN
• Patient Sex: Unknown