Atellica™ IM HBcT 10995597Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00630414599205), received between Aug 30, 2023 and May 2, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (P040004); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTS AN OBSERVATION OF FALSE NEGATIVE (NON-REACTIVE) ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT) RESULTS WHICH WERE CONSIDERED DISCORDANT RELATIVE TO REPEAT TESTING ON ALTERNATE METHODS. THE ATELLICA IM HBCT INSTRUCTIONS FOR USE (IFU) STATES THE CUTOFF FOR THE ASSAY IS 0.50 INDEX. HOWEVER THE CUSTOMER SET THE REFERENCE RANGE OF 0-1 INDEX FOR NON-REACTIVE RESULTS. AN INITIAL NEGATIVE (NON-REACTIVE) HBCT RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE NEGATIVE RESULT OBTAINED WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED ON THE ORIGINAL ATELLICA IM ANALYZER AND OBTAINED A SIMILAR NEGATIVE (NON-REACTIVE) RESULT. THE SAME SAMPLE WAS RETESTED ON ALTERNATE TEST METHODS AND OBTAINED POSITIVE (REACTIVE) RESULTS. THESE REPEAT RESULTS WERE CONSIDERED CORRECT SINCE THEY MATCHED THE CLINICAL DIAGNOSIS OF THE PATIENT, AND THE ALTERNATE TEST METHOD 1 RESULT WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN(S). A CORRECTED REPORT WAS ISSUED BASED ON THE REPEAT TESTING. THERE ARE NO KNOWN REPORTS OF DELAY, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948785 ↗
• MalfunctionDec 8, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANT, NON-REACTIVE ANTI-HEPATITIS B CORE TOTAL (HBCT) RESULT ON A PATIENT SAMPLE USING LOT 190 ON AN ATELLICA IM 1600 ANALYZER. THE NON-REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE INITIAL SAMPLE WAS RETESTED ON AN ALTERNATE INSTRUMENT, IMMULITE 2000 INSTRUMENT, THE SAMPLE PRODUCED A ¿POSITIVE¿ RESULT. THE POSITIVE RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NON-REACTIVE HBCT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290268 ↗
• MalfunctionDec 8, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANT, NON-REACTIVE ANTI-HEPATITIS B CORE TOTAL (HBCT) RESULT ON A PATIENT SAMPLE USING LOT 190 ON AN ATELLICA IM 1600 ANALYZER. THE NON-REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE INITIAL SAMPLE WAS RETESTED ON AN ALTERNATE INSTRUMENT, IMMULITE 2000 INSTRUMENT, THE SAMPLE PRODUCED A ¿POSITIVE¿ RESULT. THE POSITIVE RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NON-REACTIVE HBCT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290260 ↗
• MalfunctionDec 8, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANT, NON-REACTIVE ANTI-HEPATITIS B CORE TOTAL (HBCT) RESULT ON A PATIENT SAMPLE USING LOT 190 ON AN ATELLICA IM 1600 ANALYZER. THE NON-REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE INITIAL SAMPLE WAS RETESTED ON AN ALTERNATE INSTRUMENT, IMMULITE 2000 INSTRUMENT, THE SAMPLE PRODUCED A ¿POSITIVE¿ RESULT. THE POSITIVE RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NON-REACTIVE HBCT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290241 ↗
• MalfunctionDec 8, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF DISCORDANT, NON-REACTIVE ANTI-HEPATITIS B CORE TOTAL (HBCT) RESULT ON A PATIENT SAMPLE USING LOT 190 ON AN ATELLICA IM 1600 ANALYZER. THE NON-REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE INITIAL SAMPLE WAS RETESTED ON AN ALTERNATE INSTRUMENT, IMMULITE 2000 INSTRUMENT, THE SAMPLE PRODUCED A ¿POSITIVE¿ RESULT. THE POSITIVE RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NON-REACTIVE HBCT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290228 ↗
• MalfunctionSep 28, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. HBCT KIT LOT 185 WAS IN USE AT THE TIME OF THE DISCORDANT OBSERVATION. THE CUSTOMER IS PERFORMING A COMPARISON STUDY WHEREIN PREVIOUSLY-TESTED PATIENT SAMPLES ARE RE-TESTED FOR CORRELATION AGAINST A NEW METHOD. DURING THIS COMPARISON STUDY, A SAMPLE WAS IDENTIFIED FOR WHICH THE INITIAL HBCT MEASUREMENT WAS NONREACTIVE (NEGATIVE), BUT TESTING USING ATELLICA IM HBCT2 (NEW METHOD) AS WELL AS AN ADDITIONAL ALTERNATE METHOD PRODUCED REACTIVE (POSITIVE) RESULTS. THE INITIAL NONREACTIVE HBCT RESULT WAS RETROSPECTIVELY IDENTIFIED AS DISCORDANT AND POTENTIALLY FALSELY NEGATIVE BY COMPARISON WITH THE NEW TEST RESULTS. THIS 11-YEAR-OLD MALE PATIENT WAS TESTED FOR PRE-THERAPEUTIC ASSESSMENT BEFORE JAK INHIBITOR TREATMENT (RHEUMATOID ARTHRITIS). 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 17832220 ↗
• MalfunctionSep 20, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE ATELLICA IM ANTI-HEPATITIS B CORE TOTAL (HBCT) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. HBCT KIT LOT 182 WAS IN USE AT THE TIME OF THE DISCORDANT OBSERVATION. THE CUSTOMER IS PERFORMING A COMPARISON STUDY WHEREIN PREVIOUSLY-TESTED PATIENT SAMPLES ARE RE-TESTED FOR CORRELATION AGAINST A NEW METHOD. DURING THIS COMPARISON STUDY, A SAMPLE WAS IDENTIFIED FOR WHICH THE INITIAL HBCT MEASUREMENT WAS NONREACTIVE (NEGATIVE), BUT TESTING USING ATELLICA IM HBCT2 (NEW METHOD) AS WELL AS AN ADDITIONAL ALTERNATE METHOD PRODUCED REACTIVE (POSITIVE) RESULTS. THE INITIAL NONREACTIVE HBCT RESULT WAS RETROSPECTIVELY IDENTIFIED AS DISCORDANT AND POTENTIALLY FALSELY NEGATIVE BY COMPARISON WITH THE NEW TEST RESULTS. THIS 63-YEAR-OLD MALE PATIENT WAS UNDERGOING HBV SCREENING AT THE TIME DUE TO INCREASED LEVELS OF LIVER TRANSAMINASES. 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 17785755 ↗
• MalfunctionAug 30, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ANTI-HEPATITIS B CORE TOTAL (HBCT) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. HBCT LOT INFORMATION WAS REQUESTED, BUT NOT PROVIDED. IN A RETROSPECTIVE COMPARISON OF ASSAY RESULTS, ONE PATIENT¿S NONREACTIVE HBCT RESULT WAS IDENTIFIED AS DISCORDANT, AS TWO ALTERNATE-METHOD ANTI-HBC METHODS (ATELLICA IM HBCT2 AND ANOTHER MANUFACTURER'S METHOD) PRODUCED POSITIVE RESULTS FOR THE SAME PATIENT. 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 17652966 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040004. One submission often covers many models, so check the product and lot details in each record.

• Z-0103-2015 · Sep 15, 2014 · Terminated
  ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitr
• Z-0102-2015 · Sep 15, 2014 · Terminated
  Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay