MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBC II; HEPATITIS B VIRUS CORE ANTIGEN IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY

Catalog Number	09014926162
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys anti-hbc ii results from the cobas e 801 analytical unit while performing validation testing.The initial result was repeatedly positive using an abbot alinity system.The repeat result from the cobas e801 was 2.23 coi (non-reactive).No questionable result was reported outside of the laboratory.It was unknown which result was correct.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
As the qc recovery was acceptable, there was no indication of a performance issue with the reagent.Because no independent confirmation testing was available, it cannot be assessed which result is correct.The elecsys anti-hbc ii assay performed within specifications.Per product labeling for the assay, single false negative results can occur and are within the sensitivity claim of the assay.

• Brand Name: ELECSYS ANTI-HBC II
• Common Device Name: HEPATITIS B VIRUS CORE ANTIGEN IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY
• 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: 23876450
• Report Number: 1823260-2025-05311
• Device Sequence Number: 21198379
• Product Code: QHM
• UDI-Device Identifier: 07613336183106
• UDI-Public: 07613336183106
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 125804/0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: 03/31/2026
• Device Catalogue Number: 09014926162
• Device Lot Number: 82856901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/04/2026
• 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