ATELLICA IM HBC TOTAL 2 (HBCT2)
Received Mar 23, 2026 · Event occurred Mar 5, 2026
Report 1219913-2026-00060 · MDR key 24670095
Device
Generic name
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Manufacturer
Siemens Healthcare Diagnostics Products Ltd.Model number
N/ACatalog number
11200739
Lot number
06403017
Product problems
- False Negative Result
Patient
78 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES, THE FOLLOWING: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." FINDINGS." "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY IS DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS." SIEMENS IS INVESTIGATING.
Description of Event or Problem
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.