Elecsys Anti-HBs 08343594160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336154014), received between Jan 24, 2024 and Apr 26, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2024False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-HBS ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS. ALL VALUES > 11.5 IU/L INDICATE A POSITIVE VALUE. THE SAMPLE INITIALLY RESULTED IN AN ANTI-HBS VALUE OF > 1000 IU/L WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE ANALYZER AT A 1:100 DILUTION, RESULTING IN AN ANTI-HBS VALUE OF < 350 IU/L WITH A DATA FLAG. THE CUSTOMER MANUALLY DILUTED THE SAMPLE 1:2 AND REPEATED IT, RESULTING IN A RAW VALUE OF 871 IU/L, WHICH CALCULATES TO A FINAL ANTI-HBS VALUE OF 1742 IU/L WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE CUSTOMER MANUALLY DILUTED THE SAMPLE 1:5 AND REPEATED IT, RESULTING IN A RAW VALUE OF 271 IU/L, WHICH CALCULATES TO A FINAL ANTI-HBS VALUE OF 1355 IU/L WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE SAMPLE WAS REPEATED WITHOUT DILUTION, RESULTING IN AN ANTI-HBS VALUE OF 1000 IU/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2024, RESULTING IN VALUES OF 1000 IU/L WITH A DATA FLAG AND < 350 IU/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON A SECOND E801 ANALYZER AND THE SAME RESULTS WERE MEASURED. NO SPECIFIC VALUES WERE PROVIDED. THE CUSTOMER SENT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197508 ↗
• MalfunctionJan 24, 2024False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HBS IMMUNOASSAY RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER ANTI-HBS. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE HBSAG RESULTS. ON (B)(6) 2023, THE PATIENT HAD AN ANTI-HBS OF <3.5 MIU/ML, INTEPRETED AS NEGATIVE, AND AN HBSAG RESULT OF REACTIVE. THE INITIAL RESULTS WERE QUESTIONED WHICH PROMPTED A NEW SAMPLE TO BE COLLECTED FOR THE PATIENT. ON (B)(6) 2023, THE PATIENT HAD AN ANTI-HBS OF 136 MIU/ML, INTERPRETED AS POSITIVE, AND AN HBSAG RESULT OF NON-REACTIVE. THE SAMPLE WAS REPEATED AND THE RESULTS WERE CONFIRMED. ON (B)(6) 2023, THE PATIENT HAD ANOTHER SAMPLE COLLECTED AND THE ANTI-HBS RESULT WAS 173 MIU/ML, INTERPRETED AS POSITIVE, AND THE HBSAG RESULT WAS NON-REACTIVE. THE SAMPLE WAS REPEATED AND THE RESULTS WERE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571911 ↗