MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY S HBSAG REAGENT KIT; SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO

Catalog Number	06P02-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
An article by sara o.Dionne, hillary c.S.R.Akana, michael real, kimberly a.Elliott, brenden r.O¿neale ¿increased serologic reactivity with automated cmia testing and its implications for deceased donor eligibility determination in the united states¿, cell tissue bank (2025) 26:40 mentions repeat reactive results for samples with alinity s hiv ag/ab combo, alinity s htlv i/ii, alinity s anti-hcv, alinity s hbsag, and alinity s anti-hbc.It also states that some samples were discrepant to nat.These results could lead to rejection of donated tissue samples.No impact to donor management was reported.
Event or Problem Description
An article by sara o.Dionne, hillary c.S.R.Akana, michael real, kimberly a.Elliott, brenden r.O¿neale ¿increased serologic reactivity with automated cmia testing and its implications for deceased donor eligibility determination in the united states¿, cell tissue bank (2025) 26:40 mentions repeat reactive results for samples with alinity s hiv ag/ab combo, alinity s htlv i/ii, alinity s anti-hcv, alinity s hbsag, and alinity s anti-hbc.It also states that some samples were discrepant to nat.These results could lead to rejection of donated tissue samples.No impact to donor management was reported.
Additional Manufacturer Narrative
A complaint investigation for potential false reactive results for alinity s hbsag reagent included a review of trending data, labeling, device history record, and a complaint search.The complaint data for the product identified normal complaint activity for the complaint issue and no trends were identified.Labeling review concluded the labeling adequately addresses the issue.A device history record review did not identify any non-conformances or deviations.12,765 deceased donors were tested with alinity s hbsag i/ii, ln 6p02-60, whereof 6.35 % were repeat reactive.The reactive rate, as well as the specificity, assuming zero prevalence, is within specifications for the assay.Kit testing or review of field data was not performed, as the lot numbers in use were not available and the review of the provided data documented in the article showed performance within specifications for the assay.Based on the results of this investigation, the alinity s hbsag reagent, is performing as expected and no systemic issue or product deficiency was identified.

• Brand Name: ALINITY S HBSAG REAGENT KIT
• Common Device Name: SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23449354
• Report Number: 3008344661-2025-00154
• Device Sequence Number: 15472326
• Product Code: QHM
• UDI-Device Identifier: 00380740136819
• UDI-Public: (01)00380740136819
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 06P02-60
• 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
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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, SN# UNKNOWN.; ALNTY S SYSTEM, 06P16-01, SN# UNKNOWN.
• Patient Sex: Unknown