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	01/10/2026
Type of Reportable Event	Malfunction
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 included.Additional patient details are not available.
Event or Problem Description
The customer reported false reactive alinity s hiv ag/ab combo results, since starting using reagent lot 77548be00 on the alinity s system.The customer stated samples in question were sent for confirmatory testing and the results came back nonreactive using the geenius hiv-1/2 supplemental assay.The following data was provided (reference range: < 1.00 s/co nonreactive, >/= 1.00 s/co reactive): on (b)(6) 2026: (b)(6) : initial result = 1.32 s/co; repeat result = 1.31 and 1.34 s/co on (b)(6) 2026: (b)(6) : initial result = 1.05 s/co; repeat result = 1.00 and 1.01 s/co , (b)(6) : initial result = 2.29 s/co; repeat results = 2.36 and 2.40 s/co.On (b)(6) 2026: (b)(6): initial result = 1.16 s/co; repat result = 1.00 s/co on (b)(6) 2026: (b)(6): initial result = 2.23 s/co; repeat result = 2.14 and 1.89 s/co.There was no impact to patient management reported.
Event or Problem Description
The customer reported false reactive alinity s hiv ag/ab combo results, since starting using reagent lot 77548be00 on the alinity s system.The customer stated samples in question were sent for confirmatory testing and the results came back nonreactive using the geenius hiv-1/2 supplemental assay.The following data was provided (reference range: < 1.00 s/co nonreactive, >/= 1.00 s/co reactive): on (b)(6) 2026: (b)(4): initial result = 1.32 s/co; repeat result = 1.31 and 1.34 s/co.On (b)(6) 2026: (b)(4): initial result = 1.05 s/co; repeat result = 1.00 and 1.01 s/co.(b)(4): initial result = 2.29 s/co; repeat results = 2.36 and 2.40 s/co.On (b)(6) 2026: (b)(4): initial result = 1.16 s/co; repat result = 1.00 s/co.On (b)(6) 2026: (b)(4): initial result = 2.23 s/co; repeat result = 2.14 and 1.89 s/co.There was no impact to patient management reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot 77548be00 did not identify an increase in complaint activity for the complaint issue.A review of tracking and trending for the alinity s hiv ag/ab assay did not identify any trends.Device history record review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint lot and complaint issue.A review of alinity s hiv ag/ab assay reactive rates and specificity (assuming zero prevalence), and for lot 77548be00 specifically was performed utilizing field data.At f inova nokes blood donor (usa), lot 77548be00 showed relatively increased initial reactive (ir) and repeat reactive (rr) rates compared to previous used lots.The overall specificity was 99.854% at the other reviewed groups, the ir and rr rates were comparable to other lots.The overall specificity for the whole blood and plasma group was 99.985% and the peer sites was 99.968%.The complaint lot is performing within product requirements for all reviewed groups.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation, the alinity s hiv ag/ab reagent lot 77548be00 is performing as intended, no systemic issue or deficiency of the alinity s hiv ag/ab reagent was identified.

• 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: 24370331
• Report Number: 3002809144-2026-00045
• Device Sequence Number: 17346081
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: (01)00380740117184(17)260628(10)77548BE00
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 03/02/2026

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: 06/28/2026
• Device Catalogue Number: 06P01-60
• Device Lot Number: 77548BE00
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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).
• Patient Sex: Unknown