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 final 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 observed false reactive alinity s hbsag and alinity s hbsag confirmatory results generated for multiple samples.The following data was provided (reference range >/= 1.0 s/co is reactive): unit of measure = s/co sample id (b)(6) initial result on as1453 = 3.6, repeat results on as1452 = 2.4, 2.31, sample id (b)(6) initial result on as1473 = 3, repeat results on as1473 = 2.56, 2.07, sample id (b)(6) initial result on as1473 = 4.49, repeat results on as1472 = 4.36, 4.72, sample id (b)(6) initial result on as1473 = 2.84, repeat results on as1472 = 2.56, 2.81, sample id (b)(6) initial result on as1453 = 2.09, repeat results on as1452 = 1.39, 1.35, sample id (b)(6) initial result on as1473 = 2.99, repeat results on as1472 = 2.71, 2.45, sample id (b)(6) initial result on as1486 = 1.53, repeat results on as1486 = 1.36, 1.27, sample id (b)(6) initial result on as1486 = 1.37, repeat results on as1486 = 1.09, 1.16, sample id (b)(6) initial result on as1453 = 6.15, repeat results on as1452 = 2.95, 2.93, sample id (b)(6) initial result on as1453 = 20.97, repeat results on as1452 = 12, 12.35, sample id (b)(6) initial result on as1453 = 10.08, repeat results on as1452 = 6.13, 6.06, sample id (b)(6) initial result on as1452 = 3.25, repeat result = 3.27, sample id (b)(6) initial result on as1473 = 2.7, repeat results on as1472 = 2.48, 2.32.All samples confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.There was no reported impact to patient management.
Event or Problem Description
The customer observed false reactive alinity s hbsag and alinity s hbsag confirmatory results generated for multiple samples.The following data was provided (reference range >/= 1.0 s/co is reactive): unit of measure = s/co.Sample id (b)(6) initial result on (b)(6) = 3.6, repeat results on (b)(6) = 2.4, 2.31; sample id (b)(6) initial result on (b)(6) = 3, repeat results on (b)(6) = 2.56, 2.07; sample id (b)(6) initial result on (b)(6) = 4.49, repeat results on (b)(6) = 4.36, 4.72; sample id (b)(6) initial result on (b)(6) = 2.84, repeat results on (b)(6) = 2.56, 2.81; sample id (b)(6) initial result on (b)(6) = 2.09, repeat results on (b)(6) = 1.39, 1.35; sample id (b)(6) initial result on (b)(6) = 2.99, repeat results on (b)(6) = 2.71, 2.45; sample id (b)(6) initial result on (b)(6) = 1.53, repeat results on (b)(6) = 1.36, 1.27; sample id (b)(6) initial result on (b)(6) = 1.37, repeat results on (b)(6) = 1.09, 1.16; sample id (b)(6) initial result on (b)(6) = 6.15, repeat results on (b)(6) = 2.95, 2.93; sample id (b)(6) initial result on (b)(6) = 20.97, repeat results on (b)(6) = 12, 12.35; sample id (b)(6) initial result on (b)(6) = 10.08, repeat results on (b)(6) = 6.13, 6.06; sample id (b)(6) initial result on (b)(6) = 3.25, repeat result = 3.27; sample id (b)(6) initial result on (b)(6) = 2.7, repeat results on (b)(6) = 2.48, 2.32.All samples confirmed positive with alinity s hbsag confirmatory and nat testing generated a negative result.There was no reported impact to patient management.
Additional Manufacturer Narrative
Update section b3: date of event corrected from (b)(6) 2025.An investigation was performed into the customer issue of potentially false reactive results on donor samples due to a potential carryover event while using alinity s hbsag reagent, list number (ln) 6p02-60, lot 75365fz00.A ticket search by lot did not identify an increase in complaint activity for the alinity s hbsag reagent, lot 75365fz00, related to the customer reported event.The overall performance of the alinity s hbsag reagent was reviewed using field data from customers.Review of field data for the complaint lot indicated the product was performing within product requirements.Additionally, data were assessed across creative testing solutions (cts dallas), applicable peer sites, and whole blood and plasma populations.The performance of ln 6p02-60, lot 75365fz00, was within product requirements and comparable to other ln 6p02-60 lots analyzed in the comparison.A device history review was also performed and did not identify any potential nonconformances or deviations with the complaint lot related to the customer reported event.A review of historical performance data from the customer¿s alinity s system(s) confirmed that this was a single, unique event.The review also confirmed that alinity s hbsag assay performance at the customer site during this period met established specificity claims.The alinity s system utilizes multiple mechanisms at the sample wash station to clean the sample probe and reduce carryover.These mechanisms were confirmed to effectively mitigate sample carryover in internal verification studies prior to release.In addition, following the product specific instructions for use (ifu) and performing routine and as needed maintenance procedures, as outlined in the alinity s system operations manual, further supports contamination prevention.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.

• 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: 24518511
• Report Number: 3008344661-2026-00049
• Device Sequence Number: 21263556
• 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): 04/08/2026

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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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 HBSAG CONF RGT, 06P03-59, 73202FZ00.; ALNTY S HBSAG CONF RGT, 06P03-59, 73202FZ00.; 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).; 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).; ALNTY S SYSTEM, 06P16-01, (B)(6).; ALNTY S SYSTEM, 06P16-01, (B)(6).
• Patient Sex: Unknown