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

Catalog Number	06P07-61
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false repeat reactive alinity s htlv i/ii results for multiple donor samples that were negative for the nat testing.The following information was provided.The cutoff is 1.00 s/co.Sid (b)(6); initial result = 3.44 s/co reactive, repeat testing = reactive, repeat- reactive, retention tube = non-reactive, nat= negative.Sid (b)(6); initial result = 2.10 s/co reactive, repeat testing = reactive, repeat- reactive, retention tube = non-reactive, nat= negative.Sid (b)(6) ; initial result = 3.15 s/co reactive, repeat testing = reactive, repeat- reactive, retention tube = non-reactive, nat= negative.Sid (b)(6); initial result = 2.65 s/co reactive, repeat testing = reactive, repeat- reactive, retention tube = non-reactive, nat= negative.Sid (b)(6) ; initial result = 2.38 s/co reactive, repeat testing = reactive, repeat- reactive, retention tube = non-reactive, nat= negative.Sid (b)(6): initial result = 2.71 s/co reactive, repeat testing = reactive, repeat- reactive, retention tube = non-reactive, nat= negative.No impact to patient management was reported.
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.

• 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 LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 25020764
• Report Number: 1415939-2026-00012
• Device Sequence Number: 21246548
• Product Code: QHM
• UDI-Device Identifier: 00380740203672
• UDI-Public: (01)00380740203672(17)261022(10)80048MM00
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 05/07/2026

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 Catalogue Number: 06P07-61
• Device Lot Number: 80048MM00
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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)
• Patient Sex: Unknown