Atellica™ IM aHBs2 10995453Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00630414597836), received between Nov 27, 2018 and Aug 31, 2026 — classified as 59 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (31 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 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026False Positive Result

  The customer alleges an Atellica IM Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) discordant positive (reactive) result for a patient compared to negative hepatitis B serology results tested in another laboratory on an alternate method. 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 50515062 ↗
• MalfunctionJan 5, 2026False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF AN ERRONEOUS ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL RESULT FOR THIS PATIENT (TESTED (B)(6) 2025) WAS STRONGLY REACTIVE. WHEN A NEW SAMPLE WAS DRAWN AND TESTED IN (B)(6), A NONREACTIVE RESULT WAS OBTAINED. THIS WAS REPRODUCED IN REPEAT TESTING OF THIS SAMPLE, AND THE NONREACTIVE RESULT WAS ACCEPTED AS CORRECT. WHEN THE ORIGINAL SAMPLE (FROM (B)(6) WAS RE-TESTED TO INVESTIGATE, IT AGAIN PRODUCED A VERY STRONGLY REACTIVE RESULT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956854 ↗
• MalfunctionJan 5, 2026False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF AN ERRONEOUS ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL REACTIVE RESULT OF (B)(6) 2025 WAS IDENTIFIED AS FALSELY ELEVATED (FALSE POSITIVE). A SECOND SAMPLE, TESTED (B)(6) 2025, PRODUCED A NONREACTIVE RESULT WHICH WAS REPRODUCED WHEN THE INITIAL SAMPLE WAS REPEAT TESTED; THE INITIAL RESULT WAS CORRECTED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956831 ↗
• MalfunctionJan 5, 2026False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF AN ERRONEOUS ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL REACTIVE RESULT OF (B)(6) 2025 WAS IDENTIFIED AS FALSELY ELEVATED (FALSE POSITIVE). A SECOND SAMPLE, TESTED (B)(6) 2025, PRODUCED A NONREACTIVE RESULT WHICH WAS REPRODUCED IN REPEAT TESTING OF BOTH SAMPLES. THE INITIAL RESULT WAS CORRECTED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956755 ↗
• MalfunctionNov 14, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTS DISCORDANT REACTIVE (POSITIVE) ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) LOT 176 RESULTS ON A PATIENT SAMPLE RELATIVE TO ALTERNATE METHOD TESTING. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PATIENT. THE PATIENT WAS KNOWN TO BE NEGATIVE IN 2024, THEREFORE THE SAMPLE WAS RETESTED BY THE CUSTOMER AND RESULT WAS POSITIVE. SAMPLE WAS ALSO SENT TO 2 OTHER LABS, AND THE RESULTS WERE NEGATIVE AND BELIEVED TO BE CORRECT. THE NEGATIVE RESULT WAS REPORTED. 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 23560686 ↗
• MalfunctionOct 22, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION WHEN USING AHBS2 LOT: 176. A 31-YEAR-OLD FEMALE PATIENT UNDERGOING TREATMENT FOR HERPES PRODUCED REPRODUCIBLE REACTIVE ATELLICA IM AHBS2 RESULTS DESPITE LACK OF VACCINATION OR ADMINISTRATION OF GAMMA GLOBULINS. THE SAME PATIENT HAD TESTED NEGATIVE ON (B)(6) 2025. WHEN TESTED ON (B)(6), A STRONGLY REACTIVE RESULT WAS OBTAINED. THIS WAS QUESTIONED, AND THE SAMPLE WAS RE-TESTED TWO DAYS LATER ON AN ALTERNATE ATELLICA IM ANALYZER, WITH ESSENTIALLY THE SAME RESULT. THE REACTIVE RESULTS FOR THIS PATIENT ARE CONSIDERED ERRONEOUS. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357129 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED LOT REACTIVE (POSITIVE) ATELLICA IM AHBS2 RESULTS WITH LOT 175 ON ATELLICA IM S/N (B)(6). RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. WHEN THE SAMPLES WERE RETESTED ON AN ALTERNATE METHOD, RESULTS WERE NON-REACTIVE (NEGATIVE). 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 22642783 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED REACTIVE (POSITIVE) ATELLICA IM AHBS2 RESULTS ON ATELLICA IM ANALYZER S/N: (B)(6). RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. WHEN THE SAMPLES WERE RETESTED ON AN ALTERNATE METHOD, RESULTS WERE NON-REACTIVE (NEGATIVE). 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 22642340 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED REACTIVE (POSITIVE) ATELLICA IM AHBS2 RESULTS ON ATELLICA IM ANALYZER S/N (B)(6). RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. WHEN THE SAMPLES WERE RETESTED ON AN ALTERNATE METHOD, RESULTS WERE NON-REACTIVE (NEGATIVE). 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 22642240 ↗
• MalfunctionApr 2, 2025False Positive Result; False Positive Result

  THE CUSTOMER NOTIFIED SIEMENS OF A DISCORDANCE BETWEEN ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) LOT 174 PATIENT RESULT RELATIVE TO A RETEST RESULT WITH A DIFFERENT LOT. THE PATIENT WAS INITIALLY TESTED WITH ATELLICA IM AHBS2 LOT 174 AND RESULTED IN THE REACTIVE RANGE (>12 MIU/ML). THIS RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE CUSTOMER PERFORMED A RETEST OF THE SAME SAMPLE ON THE SAME ANALYZER, ON A DIFFERENT DAY, WITH A DIFFERENT REAGENT LOT (LOT 175) AS PART OF A LOOK BACK ACTIVITY. THE RETEST RESULT WAS LOWER THAN THE INITIAL RESULT. IT IS UNKNOWN WHETHER A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. 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 21750844 ↗
• MalfunctionApr 2, 2025False Positive Result; False Positive Result

  THE CUSTOMER NOTIFIED SIEMENS OF A DISCORDANCE BETWEEN ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) LOT: 174 PATIENT RESULT RELATIVE TO A RETEST RESULT WITH A DIFFERENT LOT. THE PATIENT WAS INITIALLY TESTED WITH ATELLICA IM AHBS2 LOT: 174 AND RESULTED IN THE REACTIVE RANGE (>12 MIU/ML). THIS RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE CUSTOMER PERFORMED A RETEST OF THE SAME SAMPLE ON THE SAME ANALYZER, ON A DIFFERENT DAY, WITH A DIFFERENT REAGENT LOT (LOT: 175) AS PART OF A LOOK BACK ACTIVITY. THE RETEST RESULT WAS LOWER THAN THE INITIAL RESULT. IT IS UNKNOWN WHETHER A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. 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 21750843 ↗
• MalfunctionMar 18, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A REPEAT REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2), LOT 174 RESULT ON A PATIENT SAMPLE (ID: (B)(6) WHICH WAS NOT IN ACCORDANCE WITH THE PATIENT HISTORY AND ALTERNATE METHOD TESTING. THE DISCORDANT ATELLICA IM AHBS2 REACTIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). 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 21631600 ↗
• MalfunctionMar 14, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A REPEAT REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2), LOT: 174 RESULT ON A PATIENT SAMPLE (ID: (B)(6) WHICH WAS NOT IN ACCORDANCE WITH THE PATIENT HISTORY AND ALTERNATE METHOD TESTING. THE DISCORDANT ATELLICA IM AHBS2 REACTIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). 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 21612963 ↗
• MalfunctionOct 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A REACTIVE (POSITIVE) ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT THAT WAS NON-REACTIVE (NEGATIVE) WHEN THE SAMPLE WAS TESTED ON AN ALTERNATE TEST METHOD. THE NEGATIVE RETEST WAS BELIEVED TO BE CORRECT. THE INITIAL REACTIVE RESULT WAS NOT REPORTED. THERE IS NO ALLEGATION OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514329 ↗
• MalfunctionApr 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. AHBS2 KIT LOT 164 WAS IN USE AT THE TIME. THE CUSTOMER OBTAINED REPRODUCIBLE REACTIVE AHBS2 RESULTS ON THREE TEST DATES FOR A 30-YEAR-OLD MALE PATIENT. REPEAT TESTING USING TWO ALTERNATE METHODS PRODUCED NEGATIVE RESULTS WHICH CONFLICTED WITH THE EARLIER REACTIVE RESULTS. THE CUSTOMER IS UNCERTAIN WHICH RESULTS TO CONSIDER CORRECT. DUE TO THE CONFLICTING INDICATIONS, THE REACTIVE ATELLICA IM AHBS2 RESULTS ARE CONSIDERED POTENTIAL FALSE POSITIVE OBSERVATIONS. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE. QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES WHEN THESE AHBS2 TESTS WERE RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033672 ↗
• MalfunctionApr 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. AHBS2 KIT LOT 164 WAS IN USE AT THE TIME. THE CUSTOMER OBTAINED REPRODUCIBLE REACTIVE AHBS2 RESULTS ON THREE TEST DATES FOR A 30-YEAR-OLD MALE PATIENT. REPEAT TESTING USING TWO ALTERNATE METHODS PRODUCED NEGATIVE RESULTS WHICH CONFLICTED WITH THE EARLIER REACTIVE RESULTS. THE CUSTOMER IS UNCERTAIN WHICH RESULTS TO CONSIDER CORRECT. DUE TO THE CONFLICTING INDICATIONS, THE REACTIVE ATELLICA IM AHBS2 RESULTS ARE CONSIDERED POTENTIAL FALSE POSITIVE OBSERVATIONS. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE. QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES WHEN THESE AHBS2 TESTS WERE RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033544 ↗
• MalfunctionApr 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. AHBS2 KIT LOT 164 WAS IN USE AT THE TIME. THE CUSTOMER OBTAINED REPRODUCIBLE REACTIVE AHBS2 RESULTS ON THREE TEST DATES FOR A 30-YEAR-OLD MALE PATIENT. REPEAT TESTING USING TWO ALTERNATE METHODS PRODUCED NEGATIVE RESULTS WHICH CONFLICTED WITH THE EARLIER REACTIVE RESULTS. THE CUSTOMER IS UNCERTAIN WHICH RESULTS TO CONSIDER CORRECT. DUE TO THE CONFLICTING INDICATIONS, THE REACTIVE ATELLICA IM AHBS2 RESULTS ARE CONSIDERED POTENTIAL FALSE POSITIVE OBSERVATIONS. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE. QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES WHEN THESE AHBS2 TESTS WERE RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033456 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF A REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL INDICATIONS AND ALTERNATE-METHOD TESTING. AHBS2 KIT LOT 164 WAS IN USE AT THE TIME. THE AFFECTED PATIENT WAS INITIALLY TESTED FOR AHBS2 AND HEPATITIS B SURFACE ANTIGEN; REACTIVE RESULTS WERE OBTAINED FOR BOTH TESTS (WHICH IS CLINICALLY UNEXPECTED). THE NEXT DAY, AN ALTERNATE-METHOD RESULT FOR HBSAG WAS POSITIVE. WHEN THE SAMPLE WAS SENT OUT FOR ALTERNATE-METHOD ANTI-HBS TESTING, A NEGATIVE RESULT WAS OBTAINED. THE NEGATIVE AHBS RESULT WAS ACCEPTED AS CORRECT, AS SIMULTANEOUS REACTIVE RESULTS FOR BOTH HBS AND ANTI-HBS IS CONSIDERED CLINICALLY INCONSISTENT. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000062 ↗
• MalfunctionMar 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF A REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL INDICATIONS AND ALTERNATE-METHOD TESTING. AHBS2 KIT LOT 164 WAS IN USE AT THE TIME. THE REACTIVE ATELLICA IM AHBS2 RESULT CONFLICTS WITH A NONREACTIVE/NEGATIVE AHBS RESULT FROM AN ALTERNATE METHOD TEST. ADDITIONALLY, ELEVATED REACTIVE HBSII (HEPATITIS B SURFACE ANTIGEN) RESULTS ARE SAID TO INDICATE THAT THE REACTIVE AHBS2 RESULT IS FALSELY POSITIVE. IT IS INDICATED THAT INTERFERENCE BY HETEROPHILIC ANTIBODIES HAS BEEN EXCLUDED. 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 18852009 ↗
• MalfunctionMar 6, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF A REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL INDICATIONS AND ALTERNATE-METHOD TESTING. AHBS2 KIT LOT 164 WAS IN USE AT THE TIME. THE REACTIVE ATELLICA IM AHBS2 RESULT CONFLICTS WITH A NONREACTIVE/NEGATIVE AHBS RESULT FROM AN ALTERNATE METHOD TEST. ADDITIONALLY, ELEVATED REACTIVE HBSII (HEPATITIS B SURFACE ANTIGEN) RESULTS ARE SAID TO INDICATE THAT THE REACTIVE AHBS2 RESULT IS FALSELY POSITIVE. IT IS INDICATED THAT INTERFERENCE BY HETEROPHILIC ANTIBODIES HAS BEEN EXCLUDED. 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 18851949 ↗
• MalfunctionFeb 21, 2024False Positive Result; False Positive Result

  A CUSTOMER OBTAINED A DISCORDANT REACTIVE (POSITIVE) RESULT WITH ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) THAT WAS NON-REACTIVE (NEGATIVE) WHEN THE SAME SAMPLE WAS TESTED ON AN ALTERNATE METHOD. THE INITIAL REACTIVE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. A CORRECTED REPORT WAS ISSUED. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT REACTIVE AHBS2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753966 ↗
• MalfunctionNov 9, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REACTIVE (POSITIVE) ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. AHBS2 REAGENT LOT 161 WAS IN USE. WHEN THIS SAMPLE WAS REPEAT-TESTED, THE INITIAL POSITIVE RESULT WAS REPRODUCED. THESE POSITIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER QUESTIONED THE REACTIVE/POSITIVE RESULTS FROM THE ATELLICA IM ASSAYS, AS THE PATIENT HAS A HISTORY OF EARLIER NEGATIVE RESULTS. THE SAMPLE WAS TESTED USING AN ALTERNATE PLATFORM, AND A LOWER RESULT WAS OBTAINED; THIS RESULT WAS ACCEPTED AS CORRECT AND REPORTED TO THE PHYSICIAN., RELATIVE TO THE INITIAL ATELLICA IM RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18106810 ↗
• MalfunctionAug 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTS AN OBSERVATION OF A FALSE POSITIVE RESULT ON ATELLICA IM HEPATITIS B SURFACE ANTIGEN ANTIBODIES 2 (AHBS2) FOR A PATIENT SAMPLE COMPARED TO THE CLINICAL PICTURE, WHEN USING REAGENT LOT 161. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563285 ↗
• MalfunctionAug 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTS AN OBSERVATION OF A FALSE POSITIVE RESULT ON ATELLICA IM HEPATITIS B SURFACE ANTIGEN ANTIBODIES 2 (AHBS2) FOR A PATIENT SAMPLE COMPARED TO THE CLINICAL PICTURE, WHEN USING REAGENT LOT 161. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563283 ↗
• MalfunctionAug 16, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED OBSERVATION OF A DISCORDANT ELEVATED (POSITIVE) ANTI - HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT, ON A FEMALE PATIENT SAMPLE ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME ATELLICA IM ANALYZER, AND THE RESULTS WERE COMPARABLE. THE SAME SAMPLE WAS TESTED ON AN ALTERNATE METHOD, WHICH GAVE A LOWER (NEGATIVE) RESULT COMPARED TO THE ATELLICA IM AHBS2 INITIAL RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED (POSITIVE) AHBS2 PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555254 ↗