MAUDE Adverse Event Report: Abbott GmbH Alinity i Anti-HCV Reagent Kit; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Catalog Number	08P05-21
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false nonreactive alinity i anti-hcv results on a patient.The results provided were: initial=0.33 s/co (< 1.00 s/co=nonreactive) /repeated =0.33 and 0.34 s/co previous history in april on cobas platform=6.88.There was no reported impact to patient management.
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.

• Brand Name: Alinity i Anti-HCV Reagent Kit
• Common Device Name: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• 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 ; +49()6122582960
• MDR Report Key: 50195581
• Report Number: 3002809144-2026-00217
• Device Sequence Number: 6099399
• Product Code: MZO
• UDI-Device Identifier: 00380740130657
• UDI-Public: (01)00380740130657(17)261207(10)84261BE00
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050042
• 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): 10/02/2026

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: 08P05-21
• Device Lot Number: 84261BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: 10/02/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (b)(6).
• Patient Sex: Unknown