Elecsys Anti-HCV II 06368921160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613336154304), received between Sep 19, 2025 and Sep 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (3 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED A DISCREPANT REACTIVE RESULT FOR SAMPLE VM-10 FROM AN API SURVEY USING THE ANTI-HCV G2 ELECSYS ASSAY ON THE COBAS 6000 E601 MODULE. THE RESULT WAS EXPECTED TO BE NON-REACTIVE BUT RECOVERED AS REACTIVE. THE CUSTOMER RE-RAN THE API SURVEY MATERIAL, AND THE SAME FALSE POSITIVE RESULT WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094360 ↗
• MalfunctionSep 19, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED A FAILURE OF THE ANTI-HCV G2 ELECSYS COBAS E 100 ASSAY ON THE COBAS 6000 E601 MODULE DURING AN API SURVEY. THE CUSTOMER REPORTED THAT SAMPLE (B)(6), WHICH WAS EXPECTED TO RESULT AS NONREACTIVE, INSTEAD RESULTED AS REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094359 ↗
• MalfunctionSep 19, 2025False Positive Result; Incorrect Measurement; False Positive Result; Incorrect Measurement

  THE INITIAL REPORTER ALLEGED A DISCREPANT REACTIVE RESULT FOR A SAMPLE (VM-10) TESTED USING THE ANTI-HCV G2 ELECSYS ASSAY ON THE COBAS 6000 E601 MODULE. THE SAMPLE WAS PART OF AN API SURVEY, WHERE THE EXPECTED RESULT WAS NON-REACTIVE. THE INITIAL TEST RESULT FOR THE SAMPLE WAS 1.40 COI (REACTIVE). THE SAMPLE WAS MANUALLY LOADED INTO A PRIMARY TUBE. ON (B)(6) 2020, THE SAMPLE WAS RETESTED ON THE SAME SYSTEM, YIELDING A RESULT OF 1.45 COI (REACTIVE). THE SAMPLE WAS THEN SENT TO A SISTER HOSPITAL, WHERE IT WAS TESTED AGAIN AND REMAINED REACTIVE. TO VERIFY THE ANALYZER'S PERFORMANCE, THE CUSTOMER RERAN A KNOWN NEGATIVE SAMPLE, WHICH PRODUCED A NON-REACTIVE RESULT. QUALITY CONTROL (QC) WAS REPORTED TO BE WITHIN SPECIFICATIONS. THE CUSTOMER SUSPECTED A SAMPLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094356 ↗