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	12/21/2025
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer reported false reactive alinity s hbsag and alinity s hbsag and alinity s hbsag confirmatory.The customer reported that the following samples were repeat reactive for alinity s hbsag and confirmed with alinity s hbsag confirmatory the customer reported that further supplemental testing was performed.Nat testing generated negative results.The customer reported that testing occurred between (b)(6) 2025 and provided the following data: reference range: = 1.0 s/co is reactive sample id (b)(6) hbsag results were 3.88, 2.95 & 2.45.Results generated from alinity s analyzer sn: (b)(6).Sample confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.Sample id (b)(6) hbsag results were 152.90, 148.10, & 147.71.Results generated from alinity s analyzer sn: (b)(6).Sample confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.Sample id (b)(6) hbsag result was 17.37.Sample confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.Sample id (b)(6) hbsag result was 10.08, 6.13 & 6.06.Results generated from alinity s analyzer sn: (b)(6).Sample confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.Sample id (b)(6) hbsag results were 1.73, 1.57, & 1.58.Results generated from alinity s analyzer sn: (b)(6).Sample confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.The customer reported that nucleic acid testing with grifols panther was a pooled sample with a pool size of 16.The customer confirmed that the patients have not received hepatis b vaccine series recently and communicated that the positive results are inconsistent with previous donor history.The donors are routine plasma donors.No other patient information was provided.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review, and field data 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 potential non-conformances, non-conformances, or deviations with the complaint lot related to the customer reported event.Ticket search by lot did not identify an increase in complaint activity for the complaint lot and for the alinity s hbsag reagent related to the customer reported event.The overall performance of the alinity s hbsag reagent was reviewed using field data from customers.A review of field data for the overall performance of the complaint lot indicated the product was performing within product requirements.Labeling was reviewed and was found to address the customer reported issue.Based on the results of the investigation, alinity s hbsag reagent lot 75365fz00 met performance requirements and no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reported false reactive alinity s hbsag and alinity s hbsag and alinity s hbsag confirmatory.The customer reported that the following samples were repeat reactive for alinity s hbsag and confirmed with alinity s hbsag confirmatory the customer reported that further supplemental testing was performed.Nat testing generated negative results.The customer reported that testing occurred between (b)(6) 2025 and provided the following data: reference range: = 1.0 s/co is reactive.Sample id (b)(6) hbsag results were 3.88, 2.95 & 2.45.Results generated from alinity s analyzer sn: (b)(6).Sample confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.Sample id (b)(6) hbsag results were 152.90, 148.10, & 147.71.Results generated from alinity s analyzer sn: (b)(6).Sample confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.Sample id (b)(6) hbsag result was 17.37.Sample confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.Sample id (b)(6) hbsag result was 10.08, 6.13 & 6.06.Results generated from alinity s analyzer sn: (b)(6).Sample confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.Sample id (b)(6) hbsag results were 1.73, 1.57, & 1.58.Results generated from alinity s analyzer sn: (b)(6).Sample confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.The customer reported that nucleic acid testing with grifols panther was a pooled sample with a pool size of 16.The customer confirmed that the patients have not received hepatis b vaccine series recently and communicated that the positive results are inconsistent with previous donor history.The donors are routine plasma donors.No other patient information was provided.There was no reported impact to patient management.

• 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: 24246864
• Report Number: 3008344661-2026-00020
• Device Sequence Number: 18540002
• Product Code: QHM
• UDI-Device Identifier: 00380740136819
• UDI-Public: (01)00380740136819(17)260418(10)75365FZ00
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 04/18/2026
• Device Catalogue Number: 06P02-60
• Device Lot Number: 75365FZ00
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• 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