MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	06P16-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported error message sample probe 1 z motor failure on the alinity's processing module.During the site visit, the field service representative (fsr) observed evidence of burning on the cable, s r1 cicoil, which in between the z-motor and 6-axis board on the alinity's processing module.The fsr replaced the affected cable, s r1 cicoil, which resolved the issue.There were no patient involvement and no harm to user reported.No additional impact to user safety was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
During the site visit by the abbott ambassador the analyzer was inspected and discovered sample probe 1 cicoil cable to be warm to the touch with one of its internal cables blackened.The cable, s-r1 cicoil (part number b-30105525-06) was replaced and the instrument functioned as intended.A review of the instrument service history identified no contributing factors to the current complaint and no additional occurrences related to a blackened cicoil have been reported.The alinity s system service documentation provides adequate information for electrical hazards during operation and maintenance and for the removal and replacement of the cable, s-r1 cicoil (part number b-30105525-06).The alinity s system operations manual provides adequate information for performing an emergency shutdown on the instrument, regarding electrical hazards, and troubleshooting for observed message code.The power supply, cable, connectors, and associated electronics have been certified to meet ul safety standards and meets ce marking, including emc, low voltage, and radio equipment directives and ivd regulation.The control measure to prevent a fire in the case of electrical fault is that the power supply operates on a secondary low voltage (48 vdc), has current limiting circuitry built-in to the power supply and has a fuse on the circuit to limit power delivered if a fault occurs.Based on the available information, no systemic issue or deficiency of the cable, s-r1 cicoil or the alinity c processing module, serial number (b)(6) was identified.
Event or Problem Description
The customer reported error message sample probe 1 z motor failure on the alinity's processing module.During the site visit, the field service representative (fsr) observed evidence of burning on the cable, s r1 cicoil, which in between the z-motor and 6-axis board on the alinity's processing module.The fsr replaced the affected cable, s r1 cicoil, which resolved the issue.There were no patient involvement and no harm to user reported.No additional impact to user safety was reported.

• Brand Name: ALINITY S SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24192155
• Report Number: 1628664-2026-00001
• Device Sequence Number: 20800597
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BL125674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 06P16-01
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown