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

Catalog Number	08837058190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).Calibration and qc were acceptable.No issues were identified during a review of the alarm trace data.Product labeling states for all initially indeterminate samples: "retest in duplicate with the elecsys anti-hcv ii assay." for all initially positive samples: "presumptive hcv infection, follow cdc recommendations for supplemental testing." single false positive results can occur and are covered by the specificity claim.A general reagent issue can be excluded.The reagent performed within specification.
Event or Problem Description
The initial reporter complained of a discrepant positive result for 1 tested for elecsys anti-hcv ii (anti-hcv ii) on a cobas e 801 analytical unit.The initial result from the e801 analyzer was 14.7 coi (positive).The repeat result from the e801 analyzer was 15.0 coi (positive).On (b)(6) 2026, the result from the abbott alinity method was 0.99 s/co (negative).On (b)(6) 2026, the hcv rna result from a cobas 5800 was hcv target not detected.

• 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: 24313220
• Report Number: 1823260-2026-00469
• Device Sequence Number: 4837632
• Product Code: MZO
• UDI-Device Identifier: 07613336166994
• UDI-Public: 07613336166994
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 02/11/2026

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: 09/30/2026
• Device Catalogue Number: 08837058190
• Device Lot Number: 87580701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/11/2026
• 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 Age: 43 YR
• Patient Sex: Male