MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; HEPATITIS C ANTIBODY ASSAY

Catalog Number	08837058190
Medical Device Problem Codes	False Positive Result (1227); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable false positive elecsys anti-hcv ii results from the cobas e 801 analytical unit.The initial result was 22.9 coi (reactive).On (b)(6) 2026, a new sample was received for the patient, and the results were 20 and 22 coi (reactive).Due to medical guidelines, the patient was instructed to repeat testing in two other laboratories, which both obtained negative results.The customer did not have the reports corresponding to the negative results but believes they were tested using an abbott alinity device.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The provided calibration and qc data was within the expected ranges.The investigation determined that reactive results may occur in elecsys ahcv ii as the assay specificity is less than 100%.Per product labeling: all initially reactive samples (results = 0.9 coi) should be re-determined in duplicate with the elecsys anti- hcv ii assay.Repeatedly reactive samples must be confirmed according to recommended confirmatory algorithms.Confirmatory tests include immuno blot and hcv rna tests.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The elecsys anti-hcv ii assay performed within specification.

• Brand Name: ELECSYS ANTI-HCV II
• Common Device Name: HEPATITIS C ANTIBODY ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 25020096
• Report Number: 1823260-2026-01672
• Device Sequence Number: 10295477
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K221693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: 08837058190
• Device Lot Number: 889619
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown