BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 24187107 · Received January 27, 2026

    Report

    Report Number
    3008344661-2026-00014
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    January 11, 2026
    Report Date
    February 11, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740160104
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P08 (ALINITY I HBSAG) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53 (ARCHITECT HBSAG) WITH 510K/PMA/BLA NUMBER P110029.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IN SECTION H6: MEDICAL DEVICE PROBLEM CODE THE COMPLAINT INVESTIGATION FOR FALSE NONREACTIVE ALINITY I HBSAG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING, AND SCIENTIFIC LITERATURE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I HBSAG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 77663FZ01. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. IN HOUSE CLINICAL SENSITIVITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 77663FZ01 STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. PER LITERATURE REVIEW OF ARTICLES, H. W. REESINK ET AL. ¿OCCULT HEPATITIS B INFECTION IN BLOOD DONORS.¿ AND MICHAEL TORBENSON AND DAVID L THOMAS. ¿OCCULT HEPATITIS B.¿, THIS COULD POTENTIALLY BE A CASE OF OCCULT HBV INFECTION WHICH IS A KNOWN PHENOMENON AND IS DIAGNOSED WHEN A HBV DNA TEST IS POSITIVE BUT HBSAG IS UNDETECTED. OCCULT INFECTION MAY REPRESENT ACUTE INFECTION IN THE WINDOW PERIOD, HBV TAILEND OF CHRONIC HBV INFECTION, PERSISTENCE OF REPLICATION AT LOW LEVEL AFTER RECOVERY IN THE PRESENCE OF ANTI-HBS OR OCCURRENCE OF AN ESCAPE MUTANT IN VACCINATED OR UNVACCINATED INDIVIDUALS NOT DETECTED BY CURRENT HBSAG ASSAYS. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I HBSAG ASSAY FOR LOT 77663FZ01 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ALINITY I HBSAG RESULT FOR A 34-YEAR-OLD FEMALE PATIENT THAT IS 22-WEEKS PREGNANT. THE PATIENT WAS ADMITTED FOR ACUTE LIVER FAILURE ON (B)(6) 2026. AS A RESULT OF THE NEGATIVE HBSAG RESULT THE ANTIVIRAL MEDICATION WAS NOT ADMINISTERED. ON (B)(6) 2026, THE CUSTOMER REPORTED THE PATIENT WAS TREATED FOR HEPATITIS B CLINICALLY; HOWEVER, THE SPECIFIC TREATMENT WAS NOT PROVIDED. THE PATIENT IS HOSPITALIZED AND CONTINUING TO RECEIVE TREATMENT. THE CUSTOMER REPORTED THEY ARE ONLY QUESTIONING THE NEGATIVE HBSAG RESULT AS BEING INCORRECT. THE FOLLOWING RESULTS AND INFORMATION WERE PROVIDED: (B)(6) 2026 RESULTS AT ANOTHER HOSPITAL WITH UNKNOWN PLATFORM: HBSAG = 0.41 IU/ML (+) (REFERENCE RANGE < 0.05), HEPATITIS B SURFACE ANTIBODY (ANTI HBS): POSITIVE, HEPATITIS B E ANTIGEN (HBEAG): NEGATIVE, HEPATITIS B E ANTIBODY (ANTI HBE): POSITIVE, HEPATITIS B CORE ANTIBODY (ANTI HBC): POSITIVE (B)(6) 2026 SID (B)(6) ALINITY RESULTS: HBSAG: 0.015 IU/ML (-), ANTI HBS: 26.549 (+), HBEAG: 0.374 S/CO (-), ANTI HBE: 0.131 S/CO (+), ANTI HBC: 4.238 S/CO (+). (B)(6) 2026 SAMPLE SENT ROCHE AND AUTOBIO (ANTU) PLATFORMS FOR TESTING: ROCHE HBSAG (QUALITATIVE) WAS 1.1, WEAKLY POSITIVE (REFERENCE RANGE <¿1), HBSAG (QUANTITATIVE) WAS <0.05, AND HBSAB WAS POSITIVE AUTOBIO PLATFORM HBSAG = NEGATIVE. (B)(6) 2026 DNA SAMPLE RESULTS: HBSAG: ABBOTT RESULT = 0.398 (+), ROCHE RESULT = 10.3 (+) QUALITATIVE AND 0.36 (+) QUANTITATIVE. HBSAB: ABBOTT RESULT = 3.188 (-), ROCHE RESULT = 4.56 (-). HBEAG: ABBOTT RESULT = 0.064 (-), ROCHE RESULT = 0.09 (-). HBEAB: ABBOTT RESULT = 0.167 (+), ROCHE RESULT = 0.03 (+). HBCAB: ABBOTT RESULT = 4.187 (+), ROCHE RESULT = 0.01 (+). HBCAB IGM: ABBOTT RESULT = 49.91 S/CO (+), ROCHE RESULT = NOT REPORTED. (B)(6) 2026 TUMOR SAMPLE RESULTS: HBSAG: ABBOTT RESULT = 0.004 (-), ROCHE RESULT = 0.761 (-) QUALITATIVE AND 0.146 QUANTITATIVE. HBSAB: ABBOTT RESULT = 3.359 (-), ROCHE RESULT = 3.99 (-). HBEAG: ABBOTT RESULT = NOT REPORTED, ROCHE RESULT = 0.0842 (-). HBEAB: ABBOTT RESULT = NOT REPORTED, ROCHE RESULT = 0.0254 (+). HBCAB: ABBOTT RESULT = NOT REPORTED, ROCHE RESULT = NOT REPORTED. HBCAB IGM: ABBOTT RESULT = 50.37 S/CO (+), ROCHE RESULT = NOT REPORTED. (B)(6) 2026 HEPATITIS B DNA, AND THE RESULT WAS: 1.6E+04IU/ML (+). THE CUSTOMER RETESTED THE PATIENT ON 16JAN2026 WITH THE FOLLOWING RESULTS: ALINITY HBSAG = 0¿IU/ML (-); ROCHE RESULTS = QUALITATIVE HBSAG WAS 0.628 (-), QUANTITATIVE HBSAG WAS <0.05 (-) HBSAB = 1.619 (-), ROCHE RESULT = 3.43 (-) HBEAG = 0.391 (-); ROCHE RESULT = HBEAG = 0.0909 (-) HBEAB = 0.183 (+); ROCHE RESULT = 0.0366 (+) HBCAB = 4.722 (+), NO REPEAT RESULT HIGH SENSITIVITY HBV DNA REMAINED POSITIVE, ALTHOUGH NO SPECIFIC VALUE WAS PROVIDED AND THE LEVEL WAS REPORTED TO BE APPROXIMATELY ONE LOGARITHMIC UNIT LOWER THAN THE RESULT FROM (B)(6) 2026. ADDITIONAL INFORMATION AND LAB DATA: BEFORE ADMISSION, THE PATIENT HAD BEEN TAKING LEVOFLOXACIN, AMOXICILLIN, JINGFANG GRANULES, OMEPRAZOLE, AND POTASSIUM CITRATE ON THEIR OWN. AFTER ADMISSION TO THE HOSPITAL, THE EMERGENCY DEPARTMENT SUPPLEMENTED THE PATIENT¿S ALBUMIN AND PROVIDED SYMPTOMATIC TREATMENT TO PROTECT THE STOMACH AND LIVER, TO REDUCE JAUNDICE, AND TO IMPROVE COAGULATION FUNCTION. ADDITIONAL RESULTS PROVIDED: HEPATITIS E IGM 2.13 (+), PCT 2.15NG/ML, HIGH-SENSITIVITY HBV-DNA 1.6E+04IU/ML, ANTI-NUCLEAR ANTIBODY NUCLEAR SPECKLED PATTERN 1:100, D-DIMER 4.69, PROTHROMBIN TIME PT 22.3S, APTT 40.2S, ALT 1373.6U/L, AST 1715.7U/L, TBIL 148.1 UMOL/L, DBIL 117.4 UMOL/L. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ALINITY I HBSAG RESULT FOR A 34-YEAR-OLD FEMALE PATIENT THAT IS 22-WEEKS PREGNANT. THE PATIENT WAS ADMITTED FOR ACUTE LIVER FAILURE ON (B)(6) 2026. AS A RESULT OF THE NEGATIVE HBSAG RESULT THE ANTIVIRAL MEDICATION WAS NOT ADMINISTERED. ON (B)(6) 2026, THE CUSTOMER REPORTED THE PATIENT WAS TREATED FOR HEPATITIS B CLINICALLY; HOWEVER, THE SPECIFIC TREATMENT WAS NOT PROVIDED. THE PATIENT IS HOSPITALIZED AND CONTINUING TO RECEIVE TREATMENT. THE CUSTOMER REPORTED THEY ARE ONLY QUESTIONING THE NEGATIVE HBSAG RESULT AS BEING INCORRECT. THE FOLLOWING RESULTS AND INFORMATION WERE PROVIDED: (B)(6) 2026 RESULTS AT ANOTHER HOSPITAL WITH UNKNOWN PLATFORM: HBSAG = 0.41 IU/ML (+) (REFERENCE RANGE < 0.05), HEPATITIS B SURFACE ANTIBODY (ANTI HBS): POSITIVE, HEPATITIS B E ANTIGEN (HBEAG): NEGATIVE, HEPATITIS B E ANTIBODY (ANTI HBE): POSITIVE, HEPATITIS B CORE ANTIBODY (ANTI HBC): POSITIVE (B)(6) 2026 SID (B)(6) ALINITY RESULTS: HBSAG: 0.015 IU/ML (-), ANTI HBS: 26.549 (+), HBEAG: 0.374 S/CO (-), ANTI HBE: 0.131 S/CO (+), ANTI HBC: 4.238 S/CO (+) (B)(6) 2026 SAMPLE SENT ROCHE AND AUTOBIO (ANTU) PLATFORMS FOR TESTING: ROCHE HBSAG (QUALITATIVE) WAS 1.1, WEAKLY POSITIVE (REFERENCE RANGE <1), HBSAG (QUANTITATIVE) WAS <0.05, AND HBSAB WAS POSITIVE AUTOBIO PLATFORM HBSAG = NEGATIVE. (B)(6) 2026 DNA SAMPLE RESULTS: HBSAG: ABBOTT RESULT = 0.398 (+), ROCHE RESULT = 10.3 (+) QUALITATIVE AND 0.36 (+) QUANTITATIVE HBSAB: ABBOTT RESULT = 3.188 (-), ROCHE RESULT = 4.56 (-) HBEAG: ABBOTT RESULT = 0.064 (-), ROCHE RESULT = 0.09 (-) HBEAB: ABBOTT RESULT = 0.167 (+), ROCHE RESULT = 0.03 (+) HBCAB: ABBOTT RESULT = 4.187 (+), ROCHE RESULT = 0.01 (+) HBCAB IGM: ABBOTT RESULT = 49.91 S/CO (+), ROCHE RESULT = NOT REPORTED (B)(6) 2026 TUMOR SAMPLE RESULTS: HBSAG: ABBOTT RESULT = 0.004 (-), ROCHE RESULT = 0.761 (-) QUALITATIVE AND 0.146 QUANTITATIVE HBSAB: ABBOTT RESULT = 3.359 (-), ROCHE RESULT = 3.99 (-) HBEAG: ABBOTT RESULT = NOT REPORTED, ROCHE RESULT = 0.0842 (-) HBEAB: ABBOTT RESULT = NOT REPORTED, ROCHE RESULT = 0.0254 (+) HBCAB: ABBOTT RESULT = NOT REPORTED, ROCHE RESULT = NOT REPORTED HBCAB IGM: ABBOTT RESULT = 50.37 S/CO (+), ROCHE RESULT = NOT REPORTED (B)(6) 2026 HEPATITIS B DNA, AND THE RESULT WAS: 1.6E+04IU/ML (+). THE CUSTOMER RETESTED THE PATIENT ON 16JAN2026 WITH THE FOLLOWING RESULTS: ALINITY HBSAG = 0 IU/ML (-); ROCHE RESULTS = QUALITATIVE HBSAG WAS 0.628 (-), QUANTITATIVE HBSAG WAS <0.05 (-) HBSAB = 1.619 (-), ROCHE RESULT = 3.43 (-) HBEAG = 0.391 (-); ROCHE RESULT = HBEAG = 0.0909 (-) HBEAB = 0.183 (+); ROCHE RESULT = 0.0366 (+) HBCAB = 4.722 (+), NO REPEAT RESULT HIGH SENSITIVITY HBV DNA REMAINED POSITIVE, ALTHOUGH NO SPECIFIC VALUE WAS PROVIDED AND THE LEVEL WAS REPORTED TO BE APPROXIMATELY ONE LOGARITHMIC UNIT LOWER THAN THE RESULT FROM (B)(6) 2026. ADDITIONAL INFORMATION AND LAB DATA: BEFORE ADMISSION, THE PATIENT HAD BEEN TAKING LEVOFLOXACIN, AMOXICILLIN, JINGFANG GRANULES, OMEPRAZOLE, AND POTASSIUM CITRATE ON THEIR OWN. AFTER ADMISSION TO THE HOSPITAL, THE EMERGENCY DEPARTMENT SUPPLEMENTED THE PATIENT¿S ALBUMIN AND PROVIDED SYMPTOMATIC TREATMENT TO PROTECT THE STOMACH AND LIVER, TO REDUCE JAUNDICE, AND TO IMPROVE COAGULATION FUNCTION. ADDITIONAL RESULTS PROVIDED: HEPATITIS E IGM 2.13 (+), PCT 2.15NG/ML, HIGH-SENSITIVITY HBV-DNA 1.6E+04IU/ML, ANTI-NUCLEAR ANTIBODY NUCLEAR SPECKLED PATTERN 1:100, D-DIMER 4.69, PROTHROMBIN TIME PT 22.3S, APTT 40.2S, ALT 1373.6U/L, AST 1715.7U/L, TBIL 148.1 UMOL/L, DBIL 117.4 UMOL/L NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249500 ALINITY I HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 77663FZ01 00380740160104

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).