MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S CHAGAS REAGENT KIT; SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO

Catalog Number	06P08-61
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a technician was attempting to close chagas positive control vial and felt droplets hit their eye as the cap closed.The technician who is a 26-year-old male was wearing safety goggles, face mask, lab coat, and gloves.Droplets went above the rim of the goggles and contacted their eye.Blood was drawn for preliminary blood work.They will be returning to the clinic in 3 weeks for follow up blood work.The technician is doing okay and is back at work.No further impact on patient management or user safety was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was provided, no additional patient information was available.
Event or Problem Description
The customer reported that a technician was attempting to close chagas positive control vial and felt droplets hit their eye as the cap closed.The technician who is a 26-year-old male was wearing safety goggles, face mask, lab coat, and gloves.Droplets went above the rim of the goggles and contacted their eye.Blood was drawn for preliminary blood work.They will be returning to the clinic in 3 weeks for follow up blood work.The technician is doing okay and is back at work.No further impact on patient management or user safety was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, trending review, labeling review, and device history record review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any issues.Evaluation of complaint data did not identify an increase in complaint activity for the complaint issue.A review of tracking and trending did not identify any trends.Labeling was reviewed and was found to address the customer reported event.Based on the available information, no systemic issue or deficiency was identified for the alinity s chagas reagent lot number 78041mm00.

• Brand Name: ALINITY S CHAGAS REAGENT KIT
• Common Device Name: SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24501072
• Report Number: 1415939-2026-00007
• Device Sequence Number: 10456505
• Product Code: QHM
• UDI-Device Identifier: 00380740203054
• UDI-Public: (01)00380740203054(17)260816(10)78041MM00
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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 Expiration Date: 08/16/2026
• Device Catalogue Number: 06P08-61
• Device Lot Number: 78041MM00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S CHAGAS CTL US, 06P08-15, 75038MM00.
• Patient Age: 26 YR
• Patient Sex: Male