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	11/13/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed false repeat reactive alinity s htlv i/ii results for multiple donor samples that were western blot negative.The following information was obtained; however, no specific donor results were provided.All results were initial reactive, repeat reactive, and western blot negative.Sids on instrument as1429: sample id (b)(6) - (b)(6) 2026.Sample id (b)(6) - (b)(6) 2026.Sample id (b)(6) -(b)(6) 2026.Sample id (b)(6) - (b)(6) 2026.Sample id (b)(6) - (b)(6) 2026.Sample id (b)(6) - (b)(6) 2025.Sample id (b)(6) - (b)(6) 2025.Sample id (b)(6)- (b)(6) 2025.Sample id (b)(6) - (b)(6) 2025.Sid on instrument (b)(6): sample id (b)(6) - (b)(6) 2026.No impact to patient management was reported.
Event or Problem Description
The customer observed false repeat reactive alinity s htlv i/ii results for multiple donor samples that were western blot negative.The following information was obtained; however, no specific donor results were provided.All results were initial reactive, repeat reactive, and western blot negative.Sids on instrument (b)(6): sample id (b)(6) - (b)(6) 2026, sample id (b)(6)- (b)(6) 2026, sample id (b)(6) - (b)(6) 2026, sample id (b)(6) - (b)(6) 2026, sample id (b)(6) - (b)(6) 2026, sample id (b)(6) - (b)(6) 2025, sample id (b)(6) - (b)(6) 2025, sample id (b)(6) - (b)(6) 2025, sample id (b)(6) - (b)(6) 2025.Sid on instrument (b)(6): sample id (b)(6) - (b)(6) 2026.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive alinity s htlv i/ii results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Review of tracking and trending for the alinity s htlv i/ii assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 75381be00.Device history review did not identify any nonconformances, potential nonconformances, or deviations associated with the lot number and complaint issue.A review of alinity s htlv i/ii ln 6p07-60 reactive rates and specificity (assuming zero prevalence), and for lot number 75381be00 specifically was performed utilizing field data.Initial reactive rates (irr), repeat reactive rates (rrr) and specificity observed for lot 75381be00 are within product requirements and comparable to other lots analyzed in the comparison.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation the alinity s htlv i/ii reagent lot 75381be00 is performing as intended, no systemic issue or deficiency was identified.All available patient information was included.Additional patient details are not available.

• 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: 24552155
• Report Number: 3002809144-2026-00057
• Device Sequence Number: 14846074
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: (01)00380740117214(17)260616(10)75381BE00
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 06/16/2026
• Device Catalogue Number: 06P07-60
• Device Lot Number: 75381BE00
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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