MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S HIV AG/AB COMBO REAGENT KIT; SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO

Catalog Number	06P01-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false repeat reactive alinity s hiv ag/ab combo results on multiple patients.The following results were provided: on (b)(6) 2025, sid (b)(6) = 5.12 / 1.83 / 5.79 / 0.35; biorad genius was negative, on (b)(6) 2025, sid (b)(6) = 14.27 / 48.51 / 72.05 0.42 / s/co; biorad genius was negative, sid (b)(6) = 259.76 / 243.47 / 231.68 / 230.5 s/co; biorad genius was negative, sid (b)(6) = 240.04 / 227.62 / 236.70 / 281 s/co; biorad genius was reactive; nat was negative, sid (b)(6) = 364.89 / 300.76 / 285.35 / 372.4 s/co; biorad genius was reactive; nat was negative, sid (b)(6) = 7.23 / 5.09 / 5.09 s/co; biorad genius was negative sid (b)(6) = repeat reactive, repeat result = 35 s/co; biorad genius and nat were negative, sid (b)(6) = repeat reactive; biorad genius was negative, sid (b)(6) = repeat reactive; biorad genius and nat were negative, sid (b)(6) = repeat reactive; biorad genius was negative no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Section a1 patient identifier sids: (b)(6).
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Updated section b5.
Event or Problem Description
The customer reported false repeat reactive alinity s hiv ag/ab combo results on multiple patients.The following results were provided: (b)(6) 2025 sid (b)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 s/co; biorad genius was negative.(b)(6) 2025 sid (b)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 s/co; biorad genius was negative.Sid (b)(6) = 259.76 / 243.47 / 231.68 / 230.5 s/co; biorad genius was negative.Sid (b)(6) = 240.04 / 227.62 / 236.70 / 281 s/co; biorad genius was reactive; nat was negative.Sid (b)(6) = 364.89 / 300.76 / 285.35 / 372.4 s/co; biorad genius was reactive; nat was negative.Sid (b)(6) = 7.23 / 5.09 / 5.09 s/co; biorad genius was negative.Sid (b)(6) = repeat reactive, repeat result = 35 s/co; biorad genius and nat were negative.Sid (b)(6) = 45.50 / 45.75 / 49.93 / 0.11 s/co; biorad genius was negative.Sid (b)(6) = 5.72 / 1.75 / 6.15 / 0.07 s/co; biorad genius and nat were negative.Sid (b)(6) = 5.14 / 6.16 / 8.69 / 0.09 s/co; biorad genius was negative.No impact to patient management was reported.
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause alinity s hiv ag/ab combo reagent lot 74477be00 identified normal complaint activity.Field data review showed that the repeat reactive rate observed for the complaint lot meets the specificity performance claim of the package insert.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lots.This review did not identify any non-conformances, potential non-conformances, or deviations.A review of labeling concluded that the issue is sufficiently addressed.The alinity s hiv ag/ab combo assay is performing as expected and no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reported false repeat reactive alinity s hiv ag/ab combo results on multiple patients.The following results were provided: (b)(6) 2025 sid (b)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 s/co; biorad genius was negative, (b)(6) 2025 sid (b)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 s/co; biorad genius was negative, sid (b)(6) = 259.76 / 243.47 / 231.68 / 230.5 s/co; biorad genius was negative, sid (b)(6) = 240.04 / 227.62 / 236.70 / 281 s/co; biorad genius was reactive; nat was negative, sid (b)(6) = 364.89 / 300.76 / 285.35 / 372.4 s/co; biorad genius was reactive; nat was negative.Sid (b)(6) = 7.23 / 5.09 / 5.09 s/co; biorad genius was negative, sid (b)(6) = repeat reactive, repeat result = 35 s/co; biorad genius and nat were negative, sid (b)(6) = 45.50 / 45.75 / 49.93 / 0.11 s/co; biorad genius was negative, sid (b)(6) = 5.72 / 1.75 / 6.15 / 0.07 s/co; biorad genius and nat were negative, sid (b)(6) = 5.14 / 6.16 / 8.69 / 0.09 s/co; biorad genius was negative.No impact to patient management was reported.
Event or Problem Description
The customer reported false repeat reactive alinity s hiv ag/ab combo results on multiple patients.The following results were provided: (b)(6) 2025 sid (b)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 s/co; biorad genius was negative, (b)(6) 2025 sid (b)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 s/co; biorad genius was negative, sid (b)(6) = 259.76 / 243.47 / 231.68 / 230.5 s/co; biorad genius was negative, sid (b)(6) = 240.04 / 227.62 / 236.70 / 281 s/co; biorad genius was reactive; nat was negative, sid (b)(6) = 364.89 / 300.76 / 285.35 / 372.4 s/co; biorad genius was reactive; nat was negative, sid (b)(6) = 7.23 / 5.09 / 5.09 s/co; biorad genius was negative, sid (b)(6) = repeat reactive, repeat result = 35 s/co; biorad genius and nat were negative, sid (b)(6) = 45.50 / 45.75 / 49.93 / 0.11 s/co; biorad genius was negative, sid (b)(6) = 5.72 / 1.75 / 6.15 / 0.07 s/co; biorad genius and nat were negative, sid (b)(6) = 5.14 / 6.16 / 8.69 / 0.09 s/co; biorad genius was negative , no impact to patient management was reported.
Additional Manufacturer Narrative
Upon review, identified an error with section d9 - date returned to mfr: corrected to update this field from 11/11/2025 to blank.

• Brand Name: ALINITY S HIV AG/AB COMBO REAGENT KIT
• Common Device Name: SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23449114
• Report Number: 3002809144-2025-00343
• Device Sequence Number: 20851610
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: (01)00380740117184(17)260309(10)74477BE00
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: BL125679
• 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,Followup,Followup
• Report Date (Section B): 01/12/2026

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: 03/09/2026
• Device Catalogue Number: 06P01-60
• Device Lot Number: 74477BE00
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 12/09/2025; 01/08/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/26/2025; 12/10/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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 SYSTEM, 06P16-01, (B)(6).; ALNTY S SYSTEM, 06P16-01, (B)(6).; ALNTY S SYSTEM, 06P16-01, (B)(6).; ALNTY S SYSTEM, 06P16-01, (B)(6).
• Patient Sex: Unknown