ADVIA CENTAUR

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF FALSE REACTIVE (POSITIVE) ADVIA CENTAUR ANTI-HBS2 (AHBS2) RESULT FOR ONE PATIENT SAMPLE WHEN USING LOT 174 WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING USING DIFFERENT REAGENT LOT 176. SIEMENS IS EVALUATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF FALSE REACTIVE (POSITIVE) ADVIA CENTAUR ANTI-HBS2 (AHBS2) RESULT FOR ONE PATIENT SAMPLE WHEN USING LOT 174 WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING USING DIFFERENT REAGENT LOT 176. THE INITIAL REACTIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER WITH SAME REAGENT LOT, AGAIN YIELDING A REACTIVE RESULT. THE SAME SAMPLE WAS THEN REPROCESSED TWICE ON AN ALTERNATE ADVIA CENTAUR XP ANALYZER USING ANOTHER REAGENT LOT, AND BOTH RUNS PRODUCED NON-REACTIVE RESULTS. THE NONREACTIVE RESULTS WERE CONSIDERED CORRECT, AS THEY WERE IN AGREEMENT WITH THE PATIENT'S CLINICAL PICTURE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE REACTIVE AHBS2 RESULT.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2026-00079 ON 15-APR-2026. ADDITIONAL INFORMATION (29-APR-2026): SIEMENS HAS CONCLUDED THE INVESTIGATION FOR THE ISSUE REPORTED BY AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER REGARDING OBSERVATION OF FALSE REACTIVE (POSITIVE) ADVIA CENTAUR ANTI-HBS2 (AHBS2) RESULT FOR ONE PATIENT SAMPLE WHEN USING LOT 174 WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING USING DIFFERENT REAGENT LOT 176. ADDITIONAL DATA RETRIEVAL WAS NOT POSSIBLE AS THE ADVIA CENTAUR XP ANALYZER WAS NOT CONNECTED TO THE SIEMENS REMOTE SERVICE (SRS) SYSTEM. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION WAS NOT WARRANTED BECAUSE DISCORDANT RESULTS WERE NOT REPRODUCIBLE. ADDITIONAL TESTING COULD NOT BE COMPLETED DUE TO INSUFFICIENT SAMPLE VOLUME AS CONFIRMED BY THE CUSTOMER. OTHER PATIENT RESULTS WERE CONSIDERED ACCEPTABLE AND WERE TESTED WITH THE SAME REAGENT PACKS AT THE SAME TIME. NO SYSTEMIC REAGENT OR INSTRUMENT ISSUE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE PROBABLE CAUSE OF THE DISCORDANT RESULTS CANNOT BE DETERMINED. THE CUSTOMER IS OPERATIONAL. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.