Elecsys HBsAg IIRecalls & reported problems across all models

We found 5 models of Elecsys HBsAg II by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 105 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2021 and Sep 29, 2026 — classified as 105 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (68 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys HBsAg II problems

Elecsys HBsAg II models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys HBsAg II 08814848190

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  93 reports
• Elecsys HBsAg II 08814848162

  Serology tests used for infectious disease screening of blood and plasma donations
  5 reports
• Elecsys HBsAg II 07251076190

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  4 reports
• Elecsys HBsAg II 08814856160

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  2 reports
• Elecsys HBsAg II 08814864160

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  1 report

Recent Elecsys HBsAg II adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937690 ↗
• MalfunctionSep 28, 2026False Positive Result

  There was an allegation of questionable Elecsys HBsAg II results for 1 patient sample on a cobas e 801 analytical unit compared to an Abbott analyzer.The initial result was 0.9 COI (borderline). The repeat result was 0.945 COI.The sample was repeated on an Abbott analyzer and the result was 0.0 IU/mL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917598 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915516 ↗
• MalfunctionSep 23, 2026False Positive Result

  There was an allegation of questionable results with the Elecsys HBsAg II assay for a donor sample tested on the Roche instrument (details have been requested). It was reported that the patient has always been non-reactive on a non-Roche instrument. Since switching to Roche instruments, the last two times the patient has been reactive for HBsAg but then confirmed negative for HBsAg.The test was repeated as the reactive result did not match previous history.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870259 ↗
• MalfunctionSep 22, 2026False Positive Result; Non Reproducible Results

  The initial reporter questioned a positive result for 1 patient sample tested for Elecsys HBsAg II (HBsAg II) on a cobas e 801 analytical unit. The initial result was 4.97 COI (positive).The repeat results were 0.338 COI (negative) and 0.365 COI (negative). The sample was repeated, and the result was 0.359 COI (negative).The sample was repeated on the customer¿s other cobas pro analyzer, and the results were 0.399 COI (negative) and 0.326 COI (negative).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857207 ↗
• MalfunctionSep 21, 2026False Positive Result; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846206 ↗
• MalfunctionSep 10, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718093 ↗
• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  There was an allegation of questionable Elecsys HBsAg II results from the cobas e 411 disk analyzer.The customer stated that most of the HBsAg samples show low positive /borderline results at approximately 1 COI. This issue occurred repeatedly in multiple samples. No specific data or repeat testing results were provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713961 ↗
• MalfunctionAug 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50518999 ↗
• MalfunctionAug 17, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286936 ↗
• MalfunctionAug 17, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50272184 ↗
• MalfunctionAug 14, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258555 ↗
• MalfunctionAug 13, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233745 ↗
• MalfunctionAug 5, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139204 ↗
• MalfunctionJul 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086585 ↗

Other Roche Diagnostics GmbH products

• cobas e 411 Immunoassay Analyzer2 models · 1,218 reports
• cobas e 801 Immunoassay analyzer3 models · 713 reports · 1 recall
• CoaguChek XS PT strips2 models · 632 reports
• CoaguChek XS Patient Self Testing Care Kit2 models · 346 reports
• Elecsys FT3 III4 models · 283 reports
• Elecsys Estradiol III2 models · 162 reports
• Elecsys TSH4 models · 155 reports
• Sodium electrode3 models · 150 reports