Elecsys HBsAg Confirmatory Test 09127127190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613336175293), received between Nov 9, 2023 and Apr 13, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Inadequate or Insufficient Training

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG CONFIRMATORY TEST RESULTS FROM THE COBAS 6000 E601 MODULE. THE INITIAL SCREENING RESULT WAS 110.6 COI REACTIVE). THE CUSTOMER DID NOT REPEAT THE SCREENING ASSAY. THE CUSTOMER THEN TESTED THE SAMPLE USING ELECSYS HBSAG CONFIRMATORY TEST USING THE INCORRECT SAMPLE PREPARATION OPTION AND DETERMINED THE RESULT WAS POSITIVE (74.03 COI). ON (B)(6) 2026, THE CUSTOMER PERFORMED TWO MORE CONFIRMATORY TESTS FOR THIS SAMPLE USING THE OTHER SAMPLE PREPARATION OPTIONS. USING THE SECOND INCORRECT SAMPLE PREPARATION OPTION, THE CONCLUSION WAS NEGATIVE (234.4 COI). USING THE CORRECT SAMPLE PREPARATION OPTION, BUT AN INCORRECT DILUTION OF 1:10 INSTEAD OF 1:20, THE CONCLUSION WAS NEGATIVE (2374 COI). THE CUSTOMER THEN PERFORMED THE CONFIRMATORY TEST FOR THIS SAMPLE USING THE CORRECT SAMPLE PREPARATION OPTION AND CORRECT DILUTION. THE CONCLUSION WAS POSITIVE (4.39 COI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858187 ↗
• MalfunctionSep 16, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE HBSAG CONFIRMATORY ELECSYS COBAS E V2 ASSAY. THE PATIENT HAD A HISTORY OF SLIGHTLY POSITIVE HBSAG II RESULTS AND NEGATIVE OR SLIGHTLY POSITIVE HBSAG CONFIRMATORY TEST RESULTS IN PRIOR YEARS. ON (B)(6)2022, THE PATIENT SAMPLE WAS TESTED FOR HBSAG II, YIELDING THE FOLLOWING RESULTS: RUN 1: 1.16 COI; RUN 2 (AFTER CENTRIFUGATION): 1.16 COI; RUN 3: 1.28 COI; RUN 4 (USING A NEW BLOOD COLLECTION TUBE): 1.18 COI; AND RUN 5: 1.22 COI. ALL RESULTS WERE REPEATEDLY REACTIVE. THE CUSTOMER PERFORMED HBSAG CONFIRMATORY TESTING USING A NEW REAGENT LOT. THE CONFIRMATORY TEST RESULTS WERE AS FOLLOWS: POSITIVE CONTROL PLUS CONFIRMATORY REAGENT (C): 0.49 COI; POSITIVE CONTROL PLUS COMPARATOR REAGENT (D): 3.76 COI. THE CALCULATED RATIO (C/D*100) WAS 13.0%, WHICH CONFIRMED THE SAMPLE AS POSITIVE. HOWEVER, THE CUSTOMER USED 180 L + 20 L INSTEAD OF THE RECOMMENDED 270 L + 30 L VOLUMES FOR THE CONFIRMATORY TEST. DESPITE THE CONFIRMED POSITIVE RESULT, THE CUSTOMER REPORTED THE SAMPLE AS NEGATIVE BASED ON RESULTS FROM AN OUTSOURCED LABORATORY. NO NEW BLOOD SAMPLE COULD BE COLLECTED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067273 ↗
• MalfunctionMay 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER QUESTIONED NEGATIVE RESULTS FOR 4 PATIENT SAMPLES TESTED FOR ELECSYS HBSAG CONFIRMATORY TESTS (HBSAG CONFIRMATORY) ON A COBAS E 801 ANALYTICAL UNIT WHERE THE INITIAL HBSAG RESULTS WERE HIGH (POSITIVE). OF THE DATA PROVIDED, DISCREPANT RESULTS WERE IDENTIFIED FOR 1 PATIENT SAMPLE BETWEEN 2 DIFFERENT HBSAG CONFIRMATORY REAGENTS. THIS MEDWATCH WILL COVER HBSAG CONFIRMATORY REAGENT WITH MATERIAL NUMBER 09127127190. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE HBSAG CONFIRMATORY REAGENT WITH MATERIAL NUMBER 11820648122. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311831 ↗
• MalfunctionMar 26, 2024False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE HBSAG CONFIRMATORY ELECSYS RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT OF HBSAG CONFIRMATORY TEST WAS "REACTIVE". THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY. THE HBSAG RESULT FROM THE OTHER LABORATORY WAS "NEGATIVE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977392 ↗
• MalfunctionMar 26, 2024False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HBSAG CONFIRMATORY ELECSYS RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS E 801 MODULE. THE REPORTER STATED THAT THE PATIENTS ARE CONSIDERED TO BE NEGATIVE FOR HEPATITIS B. SAMPLE 1: ON (B)(6) 2023: PATIENT 1: THE HBSAG CONFIRMATORY RESULT WAS 50.500% (POSITIVE). THE RESULT OF THE HEPATITIS B VIRUS POLYMERASE CHAIN REACTION: HEPATITIS B VIRUS - DEOXYRIBOSE NUCLEIC ACID (HBVPCR: HBV-DNA) TEST WAS "NOT DETECTABLE". ON (B)(6) 2023: THE HBSAG CONFIRMATORY RESULT WAS 21.200% (POSITIVE). SAMPLE 2: ON (B)(6) 2023: THE HBSAG CONFIRMATORY RESULT WAS 28.500% (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977159 ↗
• MalfunctionNov 9, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HBSAG CONFIRMATORY ELECSYS RESULT FROM THE COBAS E 801 MODULE. THE RESULT FOR THE HBSAG CONFIRMATORY TEST WAS "POSITIVE" AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WENT TO ANOTHER MEDICAL INSTITUTION WHERE THE HBSAG TEST RESULT WAS "NEGATIVE". THE METHODOLOGY USED WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103665 ↗