Atellica™ IM HBsII 10995604Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00630414599274), received between Oct 19, 2018 and Apr 17, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND REPEAT TESTING WHEN USING LOT# 318. AN INITIAL NONREACTIVE (NEGATIVE) RESULT WAS OBTAINED FOR THE PATIENT SAMPLE IN QUESTION. THE NONREACTIVE RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND TESTED ON AN ALTERNATE ANALYZER WHICH PRODUCED A REACTIVE (POSITIVE) RESULT. PER THE ASSAY¿S INSTRUCTIONS FOR USE (IFU), THE INITIAL REACTIVE PATIENT SAMPLES SHOULD BE REPEATED IN DUPLICATE, THE BEST 2 OF 3 SHOULD BE CONSIDERED THE PATIENTS¿ INITIAL RESULT AND TO BE CONFIRMED WITH THE ATELLICA IM HBSAG CONFIRMATORY ASSAY, ADDITIONAL HBV MARKER ASSAYS, OR ANOTHER APPROVED CONFIRMATORY METHOD IF WARRANTED OR NECESSARY. THE CUSTOMER FOLLOWED THE IFU AND REPEATED THE SAMPLE IN DUPLICATE. CONSENSUS RESULT = REACTIVE. LATER, CONFIRMATORY TESTING WAS PERFORMED ON THE ORIGINAL AND ALTERNATE ANALYZERS WHICH ALSO PRODUCED REACTIVE RESULTS. THE SAME SAMPLE WAS THEN SENT OUT TO AN ALTERNATE FACILITY AND TESTED USING AN ALTERNATE METHODOLOGY WHICH ALSO PRODUCED A REA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24914443 ↗
• MalfunctionNov 21, 2025False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED A NON-REACTIVE (NEGATIVE) RESULT ON A PLASMA SAMPLE FROM A PATIENT WITH A PREVIOUS DIAGNOSIS OF CHRONIC HEPATITIS B WHEN TESTED WITH ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII) REAGENT LOT 316 ON AN ATELLICA CI ANALYZER. THE INITIAL ATELLICA CI HBSII NEGATIVE RESULT WAS REPORTED AND QUESTIONED. RETEST OF THE SAME SAMPLE WAS NEGATIVE, BUT POSITIVE ON AN ALTERNATE METHOD. THE SAME SAMPLE WAS SENT TO ANOTHER LAB AND TESTED WITH 2 OTHER METHODS (ATELLICA IM AND A DIFFERENT ALTERNATE METHOD) AND BOTH RESULTS WERE POSITIVE. THE CUSTOMER HAD A DIFFERENT TUBE (SERUM) FROM THE SAME PATIENT AND TESTED ON THE ATELLICA CI AND RESULTED POSITIVE. A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS OF ALTERED TREATMENT OR ADVERSE HEALTH CONSEQUENCES IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616652 ↗
• MalfunctionJul 11, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HEPATITIS B SURFACE ANTIGEN (HBSAG), CONFIRMATORY (HBSII CONF) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION REPEAT TESTING WHEN USING LOT# 314. AN INITIAL REACTIVE (POSITIVE) RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. PER THE ASSAY¿S INSTRUCTIONS FOR USE (IFU), THE INITIAL REACTIVE PATIENT SAMPLES SHOULD BE REPEATED IN DUPLICATE, THE BEST 2 OF 3 SHOULD BE CONSIDERED THE PATIENTS¿ INITIAL RESULT AND TO BE CONFIRMED WITH THE ATELLICA IM HBSAG CONFIRMATORY ASSAY, ADDITIONAL HBV MARKER ASSAYS, OR ANOTHER APPROVED CONFIRMATORY METHOD IF WARRANTED OR NECESSARY. THE CUSTOMER FOLLOWED THE ASSAY INSTRUCTIONS FOR USE (IFU) AND REPEATED THE SAMPLE. THE RESULTS WERE REPEATEDLY REACTIVE. THE REACTIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). A CONFIRMATORY TESTING WAS PERFORMED WHICH PRODUCED AN INITIAL REACTIVE (POSITIVE) RESULT. PER THE ASSAY'S INSTRUCTIONS FOR USE (IFU), "SAMPLES WHICH ARE NEUTRALIZED <50% BUT WHOSE RELATIVE LIGHT UNITS (RLUS) VALUE ARE ABOVE THE HBSII CONF CUTOFF, GET DILUTED 1/50". THE INSTRUMENT AUTO REPEATED THE SAMPLE WITH DILUTION (X50) THAT RESULTED IN A 'NOT CONFIRMED'

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479420 ↗
• MalfunctionJan 17, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF NONREACTIVE (NEGATIVE) ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII) RESULTS WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING WHEN USING HBSII LOT 312. THE CUSTOMER INDICATES THAT A PARTICULAR PATIENT HAS PRODUCED NEGATIVE (NONREACTIVE) HBSII RESULTS ON SEVERAL OCCASIONS (DETAILS NOT PROVIDED), AND THAT LATER TESTING SHOWED THIS PATIENT TO BE HEPATITIS B POSITIVE. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185738 ↗
• MalfunctionOct 29, 2024False Negative Result; False Negative Result

  THE CUSTOMER NOTIFIED SIEMENS OF DISCORDANT NON-REACTIVE (NEGATIVE) ATELLICA IM HBSAG (HBSII) RESULTS ON A PATIENT COMPARED TO A POSITIVE HEPATITIS B RESULT OBTAINED AT A NON-CUSTOMER FACILITY ( (B)(6) HOSPITAL). INITIALLY, THE PATIENT RESULTED NEGATIVE WITH ATELLICA IM HBSAG (HBSII) LOT 309 AT THE CUSTOMER SITE ON (B)(6) 2024. THE CUSTOMER WAS THEN MADE AWARE OF THE DISCORDANCE WHEN A NON-CUSTOMER FACILITY ( (B)(6) HOSPITAL) NOTIFIED THEM THAT THIS PATIENT HAD RESULTED AS REACTIVE FOR HEPATITIS B ON (B)(6) 2024 (METHOD UNKNOWN). AFTER BEING NOTIFIED, THE CUSTOMER TESTED THE SAME PATIENT WITH ATELLICA IM HBSAG (HBSII) ON (B)(6) 2024 AND THE RESULTS WERE NEGATIVE. THERE ARE NO ALLEGATIONS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560190 ↗
• MalfunctionOct 29, 2024False Negative Result; False Negative Result

  THE CUSTOMER NOTIFIED SIEMENS OF DISCORDANT NON-REACTIVE (NEGATIVE) ATELLICA IM HBSAG (HBSII) RESULTS ON A PATIENT COMPARED TO A POSITIVE HEPATITIS B RESULT OBTAINED AT A NON-CUSTOMER FACILITY ( (B)(6) HOSPITAL). INITIALLY, THE PATIENT RESULTED NEGATIVE WITH ATELLICA IM HBSAG (HBSII) LOT 309 AT THE CUSTOMER SITE ON (B)(6) 2024. THE CUSTOMER WAS THEN MADE AWARE OF THE DISCORDANCE WHEN A NON-CUSTOMER FACILITY (NYU HOSPITAL) NOTIFIED THEM THAT THIS PATIENT HAD RESULTED AS REACTIVE FOR HEPATITIS B ON (B)(6) 2024 (METHOD UNKNOWN). AFTER BEING NOTIFIED, THE CUSTOMER TESTED THE SAME PATIENT WITH ATELLICA IM HBSAG (HBSII) ON (B)(6) 2024 AND THE RESULTS WERE NEGATIVE. THERE ARE NO ALLEGATIONS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560054 ↗
• MalfunctionOct 29, 2024False Negative Result; False Negative Result

  THE CUSTOMER NOTIFIED SIEMENS OF DISCORDANT NON-REACTIVE (NEGATIVE) ATELLICA IM HBSAG (HBSII) RESULTS ON A PATIENT COMPARED TO A POSITIVE HEPATITIS B RESULT OBTAINED AT A NON-CUSTOMER FACILITY ((B)(6) HOSPITAL). INITIALLY, THE PATIENT RESULTED NEGATIVE WITH ATELLICA IM HBSAG (HBSII) LOT 309 AT THE CUSTOMER SITE ON (B)(6) 2024. THE CUSTOMER WAS THEN MADE AWARE OF THE DISCORDANCE WHEN A NON-CUSTOMER FACILITY ((B)(6) HOSPITAL) NOTIFIED THEM THAT THIS PATIENT HAD RESULTED AS REACTIVE FOR HEPATITIS B ON (B)(6) 2024 (METHOD UNKNOWN). AFTER BEING NOTIFIED, THE CUSTOMER TESTED THE SAME PATIENT WITH ATELLICA IM HBSAG (HBSII) ON (B)(6) 2024 AND THE RESULTS WERE NEGATIVE. THERE ARE NO ALLEGATIONS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560050 ↗
• MalfunctionJun 23, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF NONREACTIVE ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO PATIENT MEDICAL HISTORY AND ALTERNATE-METHOD TESTING. A NONREACTIVE HBSII RESULT WAS OBTAINED FOR AN 85-YEAR-OLD MALE PATIENT. THIS RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS TESTED USING AN ALTERNATE METHOD AT AN EXTERNAL LAB, AND A POSITIVE RESULT WAS RETURNED, WHICH WAS CONSIDERED CONSISTENT WITH THE PATIENT¿S MEDICAL HISTORY. THE CUSTOMER STATES THAT RE-TESTING OF THE SAMPLE FOLLOWING DILUTION (2-FOLD AND 4-FOLD) ALSO PRODUCED NONREACTIVE HBSII RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NONREACTIVE ATELLICA IM HBSAGII RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190483 ↗
• MalfunctionApr 22, 2020False Positive Result; False Positive Result

  A FALSE REACTIVE (POSITIVE) ATELLICA IM (B)(6) SURFACE ANTIGEN II ((B)(6)) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS A CANDIDATE FOR AN ORGAN TRANSPLANT THAT WAS DELAYED DUE TO THE REACTIVE (B)(6) RESULT. THE PATIENT WAS TESTED FOR (B)(6) AT TWO OTHER ALTERNATE LABORATORIES AND THE RESULTS WERE NON-REACTIVE (NEGATIVE). THE CUSTOMER PERFORMED REPEAT ATELLICA IM (B)(6) TESTING ON THE SAME PATIENT SAMPLE ONE MONTH LATER AND THE RESULTS WERE NON-REACTIVE (NEGATIVE). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN ORGAN TRANSPLANT DUE TO THE DISCORDANT ATELLICA IM (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9985495 ↗
• MalfunctionOct 19, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT (B)(6) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT IS KNOWN TO HAVE CHRONIC (B)(6). THE PREVIOUS RESULT OF THE PATIENT WAS (B)(6). THE PATIENT SAMPLE WAS REPEATED ON THE SAME ATELLICA IM SYSTEM AND THE RESULT WAS (B)(6). AN ALIQUOT OF THE SAMPLE WAS TESTED ON THE OTHER ATELLICA IM SYSTEM AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE (B)(6). PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7984427 ↗
• MalfunctionOct 19, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT NEGATIVE ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT IS KNOWN TO HAVE CHRONIC (B)(6). THE PREVIOUS RESULT OF THE PATIENT WAS (B)(6). THE PATIENT SAMPLE WAS REPEATED ON THE SAME ATELLICA IM SYSTEM AND THE RESULT WAS NEGATIVE. AN ALIQUOT OF THE SAMPLE WAS TESTED ON THE OTHER ATELLICA IM SYSTEM AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBSAGII RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7984425 ↗
• MalfunctionOct 19, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT NEGATIVE ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT IS KNOWN TO HAVE CHRONIC HEPATITIS B. THE PREVIOUS RESULT OF THE PATIENT WAS (B)(6). THE PATIENT SAMPLE WAS REPEATED ON THE SAME ATELLICA IM SYSTEM AND THE RESULT WAS NEGATIVE. AN ALIQUOT OF THE SAMPLE WAS TESTED ON THE OTHER ATELLICA IM SYSTEM AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBSAGII RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7984415 ↗