MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S HTLV I/II REAGENT KIT; SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO

Catalog Number	06P07-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Complete information for section a1 patient identifier is sid(b)(6), sid(b)(6), and sid(b)(6).
Event or Problem Description
The customer reported false repeat reactive alinity s htlv i/ii results for three donors.The following data was provided (<1.00 s/co is nonreactive, = 1.00 s/co is reactive): on (b)(6) 2025, sid(b)(6), (cadaveric sample): initial result = 2.34 s/co, repeat results = 3.29 s/co, 1.55 s/co western blot result = negative.On (b)(6) 2025, sid(b)(6), (cadaveric sample): initial result = 1.10 s/co, repeat results = 1.23 s/co, 0.26 s/co western blot result = negative.On (b)(6) 2025, sid(b)(6): initial result = 3.84 s/co, repeat results = 4.18 s/co, 3.93 s/co western blot result = indeterminate no impact to patient management was reported.
Additional Manufacturer Narrative
Additional information was provided.The following section was updated: section a1 - patient identifier: sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6).Section b5 - describe event or problem: this section was updated with additional information provided by the customer.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
Update: the customer reported 4 additional donors with false repeat reactive alinity s htlv i/ii results.The following data was provided: on (b)(6) 2025, sid(b)(6), (cadaveric sample): initial result = 2.19 s/co, repeat results = 3.98 s/co, 3.29 s/co western blot result = negative.On (b)(6) 2025, sid(b)(6), (cadaveric sample): initial result = 4.19 s/co, repeat result = 4.77 s/co, 3.12s/co western blot result = negative.On (b)(6) 2025, sid (b)(6) (cadaveric sample): initial result = 4.99 s/co, repeat results = 4.65 s/co, 5.16 s/co western blot result = negative.On (b)(6) 2025, sid (b)(6) (cadaveric sample): initial result = 3.28 s/co, repeat results = 1.71 s/co, 3.55 s/co western blot result = negative.It was noted that the previously provided sid(b)(6) was also a cadaveric sample.
Event or Problem Description
The customer reported false repeat reactive alinity s htlv i/ii results for three donors.The following data was provided (<1.00 s/co is nonreactive, = 1.00 s/co is reactive): (b)(6) 2025 sid (b)(6) (cadaveric sample): initial result = 2.34 s/co, repeat results = 3.29 s/co, 1.55 s/co, western blot result = negative.(b)(6) 2025 sid (b)(6) (cadaveric sample): initial result = 1.10 s/co, repeat results = 1.23 s/co, 0.26 s/co, western blot result = negative.(b)(6) 2025 sid (b)(6): initial result = 3.84 s/co, repeat results = 4.18 s/co, 3.93 s/co, western blot result = indeterminate, no impact to patient management was reported.Update: the customer reported 4 additional donors with false repeat reactive alinity s htlv i/ii results.The following data was provided: (b)(6) 2025 sid (b)(6) (cadaveric sample): initial result = 2.19 s/co, repeat results = 3.98 s/co, 3.29 s/co, western blot result = negative.(b)(6) 2025 sid (b)(6) (cadaveric sample): initial result = 4.19 s/co, repeat result = 4.77 s/co, 3.12s/co, western blot result = negative.(b)(6) 2025 sid (b)(6) (cadaveric sample): initial result = 4.99 s/co, repeat results = 4.65 s/co, 5.16 s/co, western blot result = negative.(b)(6) 2025 sid (b)(6) (cadaveric sample): initial result = 3.28 s/co, repeat results = 1.71 s/co, 3.55 s/co, western blot result = negative, it was noted that the previously provided sid (b)(6) was also a cadaveric sample.
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, field data review, and device history record review.A review of tracking and trending for the alinity s htlv i/ii assay did not identify trends related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 69484be00.The device history record review did not identify any non-conformances, potential non-conformances, or deviations with the complaint lot and issue.Labeling was reviewed and sufficiently addresses the customer's issue.The overall performance of the alinity s htlv i/ii reagents in the field was reviewed using data gathered from customers worldwide.Initial reactive rates (irr), repeat reactive rates (rrr) and specificity observed for lot 69484be00 are within product requirements and comparable to other lots analyzed in the comparison.Based on the investigation, the alinity s htlv i/ii reagent lot 69484be00 is performing as intended.No systemic issue or deficiency of the alinity s htlv i/ii reagent was identified.

• Brand Name: ALINITY S HTLV I/II 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: 23312632
• Report Number: 3002809144-2025-00330
• Device Sequence Number: 5788825
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: (01)00380740117214(17)251224(10)69484BE00
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BL125675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2025

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 Expiration Date: 12/24/2025
• Device Catalogue Number: 06P07-60
• Device Lot Number: 69484BE00
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 11/19/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/05/2025; 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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).
• Patient Sex: Unknown