MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number	08836981190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of false-positive elecsys anti-hcv ii results for 1 patient on a cobas e 411 analyzer (disk system).The initial result was 1.99 coi, and the repeated results were 1.99 coi and 1.98 coi (all positive).On (b)(6) 2026, the sample was retested on another module (cobas e 411), and the results were 1.88 coi and 1.820 coi (both positive).The sample was tested using the clia assay, and the result was 0.10 (negative).The unit of measure was not provided.On (b)(6) 2026, confirmation testing, using the lia assay (fujirebio hcv score), was performed with immunoblot, and the result was negative.Based on the patient's clinical background, the positive anti-hcv results are allegedly false-positive results.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The patient sample was investigated.The results were repeatedly reactive.Based on the negative immunoblot testing result, the sample's anti-hcv ii result is assumed to be falsely reactive.The investigation determined the issue is related to a sample-specific discrepancy.Single false reactive results may occur as the specificity of elecsys anti-hcv ii assay 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 investigation did not identify a product problem.The elecsys anti-hcv ii assay performs within specification.

• Brand Name: ELECSYS ANTI-HCV II
• Common Device Name: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• 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: 24913709
• Report Number: 1823260-2026-01484
• Device Sequence Number: 18610451
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/17/2026

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 08836981190
• Device Lot Number: 88776500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/17/2026
• 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