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	07/24/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a false repeat reactive alinity s htlv i/ii result on a patient (sid (b)(6) that was negative by supplemental testing.No impact to patient management was reported.
Event or Problem Description
The customer reported a false repeat reactive alinity s htlv i/ii result on a patient (sid (b)(6) that was negative by supplemental testing.No impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation for an increase in reactive rates and potential false reactive results for alinity s htlv i/ii reagent included a review of trending data, labeling, device history record, field data, and a complaint search.The complaint data for the product identified normal complaint activity for the complaint issue and no trends were identified.Labeling review concluded the labeling adequately addresses the issue.A device history record review did not identify any non-conformances or deviations.A review of field data for the overall performance of the alinity s htlv i/ii reagent indicated the product was performing within product requirements.For lot 71118be00, the initial reactive rate (irr), repeat reactive rate (rrr) and specificity (assuming zero prevalence) observed is within product requirements and comparable to other lots analyzed in the comparison.Based on the results of this investigation, alinity s htlv i/ii reagent, lot 71118be00 is performing as expected and no systemic issue or product deficiency 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: 22825533
• Report Number: 3002809144-2025-00267
• Device Sequence Number: 9522584
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: (01)00380740117214(17)260212(10)71118BE00
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/19/2025

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: 02/12/2026
• Device Catalogue Number: 06P07-60
• Device Lot Number: 71118BE00
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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)
• Patient Sex: Unknown