Atellica IM HBcT2 11200739Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00630414604138), received between Nov 7, 2023 and Jul 31, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098683 ↗
• MalfunctionJul 31, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098681 ↗
• MalfunctionMar 23, 2026False Negative Result

  THE CUSTOMER OBTAINED OF A NON-REACTIVE (NEGATIVE) PATIENT RESULT USING ATELLICA IM HBC TOTAL 2 (HBCT2) LOT 017. THE RESULT WAS NOT REPORTED AS THE PATIENT WAS KNOWN TO HAVE HEPATITIS B. THE SAMPLE WAS RETESTED USING AN ALTERNATE METHOD AND THE RESULT WAS REACTIVE (POSITIVE) AS EXPECTED. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670095 ↗
• MalfunctionSep 14, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THE CUSTOMER NOTIFIED SIEMENS OF A NON-REACTIVE (NEGATIVE) ATELLICA IM ANTI-HEPATITIS B CORE TOTAL2 (HBCT2) LOT 016 RESULT THAT WAS LATER FOUND TO BE DISCORDANT RELATIVE TO THE RETESTING OF THE PATIENT ON A DIFFERENT DATE WITH ATELLICA IM AND AN ALTERNATE METHOD. THE PATIENT WAS BEING ROUTINELY TESTED FOR HEPATITIS B SINCE 2022 AS WELL AS OTHER INFECTIOUS DISEASES. THE PATIENT RESULTED AS NEGATIVE IN (B)(6) 2025 WITH ATELLICA IM HBCT2. THE PATIENT RETURNED IN (B)(6) 2025 AND WAS TESTED AGAIN AND THE ATELLICA IM HBCT2 RESULT WAS POSITIVE. BECAUSE OF THE DISCREPANCY IN RESULTS, BOTH THE (B)(6) SAMPLES WERE RETESTED WITH AN ALTERNATE METHOD, AND RESULTS WERE POSITIVE AND BELIEVED TO BE CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048179 ↗
• MalfunctionFeb 6, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULTS WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. NONREACTIVE HBCT2 RESULTS FOR THE AFFECTED PATIENTS WERE QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLES FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. CONFLICTING POSITIVE RESULTS WERE PRODUCED BY THE ALTERNATE METHOD AND WERE ACCEPTED AS THE CORRECT RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652443 ↗
• MalfunctionFeb 6, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE HBCT2 RESULT FOR THE AFFECTED PATIENT WAS QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLE FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. A CONFLICTING POSITIVE RESULT WAS PRODUCED BY THE ALTERNATE METHOD AND WAS ACCEPTED AS THE CORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652415 ↗
• MalfunctionFeb 6, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE HBCT2 RESULT FOR THE AFFECTED PATIENT WAS QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLE FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. A CONFLICTING POSITIVE RESULT WAS PRODUCED BY THE ALTERNATE METHOD AND WAS ACCEPTED AS THE CORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652395 ↗
• MalfunctionFeb 6, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE HBCT2 RESULT FOR THE AFFECTED PATIENT WAS QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLE FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. A CONFLICTING POSITIVE RESULT WAS PRODUCED BY THE ALTERNATE METHOD AND WAS ACCEPTED AS THE CORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652347 ↗
• MalfunctionDec 12, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE HBCT2 RESULT FOR THE AFFECTED PATIENT WAS QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLE FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. A CONFLICTING POSITIVE RESULT WAS PRODUCED BY THE ALTERNATE METHOD AND WAS ACCEPTED AS THE CORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311488 ↗
• MalfunctionDec 12, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE HBCT2 RESULT FOR THE AFFECTED PATIENT WAS QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLE FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. A CONFLICTING POSITIVE RESULT WAS PRODUCED BY THE ALTERNATE METHOD AND WAS ACCEPTED AS THE CORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311486 ↗
• MalfunctionDec 12, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE HBCT2 RESULT FOR THE AFFECTED PATIENT WAS QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLE FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. A CONFLICTING POSITIVE RESULT WAS PRODUCED BY THE ALTERNATE METHOD AND WAS ACCEPTED AS THE CORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311460 ↗
• MalfunctionDec 12, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE HBCT2 RESULT FOR THE AFFECTED PATIENT WAS QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLE FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. A CONFLICTING POSITIVE RESULT WAS PRODUCED BY THE ALTERNATE METHOD AND WAS ACCEPTED AS THE CORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311454 ↗
• MalfunctionDec 12, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULTS WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. INITIAL NONREACTIVE HBCT2 RESULTS FOR THE AFFECTED PATIENTS WERE QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLES FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. CONFLICTING POSITIVE RESULTS WERE PRODUCED BY THE ALTERNATE METHOD AND WERE ACCEPTED AS THE CORRECT RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311451 ↗
• MalfunctionDec 12, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE HBCT2 RESULT FOR THE AFFECTED PATIENT WAS QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLE FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. A CONFLICTING POSITIVE RESULT WAS PRODUCED BY THE ALTERNATE METHOD AND WAS ACCEPTED AS THE CORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311449 ↗
• MalfunctionDec 12, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE HBCT2 RESULT FOR THE AFFECTED PATIENT WAS QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLE FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. A CONFLICTING POSITIVE RESULT WAS PRODUCED BY THE ALTERNATE METHOD AND WAS ACCEPTED AS THE CORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311446 ↗
• MalfunctionDec 12, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. HBCT2 KIT LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE HBCT2 RESULT FOR THE AFFECTED PATIENT WAS QUESTIONED BY LABORATORY CLINICIANS, AND NOT REPORTED. THE LABORATORY SENT THE SAMPLE FOR REPEAT TESTING AT ANOTHER LABORATORY, USING A DIFFERENT ASSAY METHOD. A CONFLICTING POSITIVE RESULT WAS PRODUCED BY THE ALTERNATE METHOD AND WAS ACCEPTED AS THE CORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311445 ↗
• MalfunctionNov 7, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF NONREACTIVE (NEGATIVE) ATELLICA IM HBC TOTAL 2 (HBCT2) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. HBCT2 LOT 008 WAS IN USE AT THE TIME. A NONREACTIVE (NEGATIVE) HBCT2 RESULT WAS OBTAINED FOR A 28-YEAR-OLD MALE PATIENT WITH A HISTORY OF A POSITIVE AHBCT RESULT 6 MONTHS EARLIER. THIS NEGATIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN. RE-TESTING OF THE SAME SAMPLE USING THE ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT) TEST PRODUCED A REACTIVE (POSITIVE) RESULT. THE CUSTOMER SENT THIS PATIENT¿S SAMPLE TO ANOTHER LABORATORY FOR CONFIRMATION. 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 18085150 ↗