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); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The other e 801 analyzer serial number was not provided.The calibration and qc recovery data provided was within specification.Single false reactive results may occur as the specificity is less than 100%.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The product performs within specification.No product problem was identified.
Event or Problem Description
There was an allegation of questionable elecsys anti-hcv ii results for 2 patient samples on a cobas e 801 analytical unit compared to an abbott analyzer.On (b)(6) 2026, sample 1 had an initial result of 24.7 coi (reactive).On (b)(6) 2026, the sample was repeated on another e 801 analyzer and the result was 25.0 coi (reactive).The sample was also repeated on an abbott analyzer and the result was 0.48 coi (non-reactive).The sample was also sent for confirmatory molecular testing and the result was non-reactive.On (b)(6) 2026, sample 2 had an initial result of 22.9 coi (reactive).On (b)(6) 2026, the sample was repeated and the result was 25.4 coi (reactive).The sample was also repeated on an abbott analyzer and the result was 0.91 coi (non-reactive).The sample was also sent for confirmatory molecular testing and the result was non-reactive.

• 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: 25488127
• Report Number: 1823260-2026-02338
• Device Sequence Number: 21431327
• 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): N
• 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): 06/12/2026

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: 913968
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/12/2026
• 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