ARCHITECT ANTI-HBS
Report
- Report Number
- 3008344661-2025-00170
- Event Type
- Malfunction
- Date Received
- December 4, 2025
- Date of Event
- November 14, 2025
- Report Date
- December 23, 2025
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- LOM
- UDI-DI
- 00380740165352
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 07C18, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 01L82 (AUSAB), AND A PMA NUMBER OF P050051.
THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT ANTI-HBS RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCT AND THE COMPLAINT LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. USING WORLDWIDE FIELD DATA, THE HISTORICAL PERFORMANCE OF THE REAGENT WAS EVALUATED AND THE PATIENT MEDIAN RESULT FOR THE LOT IS COMPARABLE WITH ALL OTHER LOTS IN THE FIELD AND WITHIN ESTABLISHED BASELINES, CONFIRMING NO SYSTEMIC ISSUE FOR THE PRODUCT LOT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOT NUMBER AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE COMPLAINT LOT NUMBER WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. REVIEW OF THE PUBLICATION, TATE AND WARD (2004), ¿INTERFERENCES IN IMMUNOASSAY¿, CLIN BIOCHEM REV, VOL 25, 105, ANALYTICAL INTERFERENCE CAN LEAD TO FALSELY ELEVATED RESULTS AND ACCORDING TO THE LITERATURE, THERE IS NO SINGLE PROCEDURE THAT CAN RULE OUT ALL INTERFERENCES. IT IS IMPORTANT TO RECOGNIZE THE POTENTIAL FOR INTERFERENCE IN IMMUNOASSAY AND TO PUT PROCEDURES IN PLACE TO IDENTIFY THEM WHEREVER POSSIBLE. MOST IMPORTANT IS A CONSIDERATION OF THE FINAL CLINICAL PICTURE. IF THERE IS ANY CLINICAL SUSPICION OF DISCORDANCE BETWEEN THE CLINICAL AND THE LABORATORY DATA AN ATTEMPT SHOULD BE MADE TO RECONCILE THE DIFFERENCE. THE DETECTION OF INTERFERENCE MAY REQUIRE THE USE OF AN ALTERNATE ASSAY, OR MEASUREMENT BEFORE AND AFTER TREATMENT WITH ADDITIONAL BLOCKING REAGENT OR FOLLOWING DILUTION OF THE SAMPLE IN NON-IMMUNE SERUM. ADDITIONALLY, PER PUBLICATION, P. COLSON. ET AL., ¿CLINICAL AND VIROLOGICAL SIGNIFICANCE OF THE CO-EXISTENCE OF HBSAG AND ANTI-HBS ANTIBODIES IN HEPATITIS B CHRONIC CARRIERS¿, VIROLOGY 367 (2007) 30¿40, THERE IS EVIDENCE FROM ANOTHER STUDY INDICATING THAT ANTI-HBS CO-EXISTENCE IN HBSAG-POSITIVE PATIENTS IS POSSIBLE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ARCHITECT ANTI-HBS, LOT NUMBER 73391FZ01, WAS IDENTIFIED.
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT ANTI-HBS RESULTS FOR A MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (>/=10 MIU/ML IS PROTECTED AGAINST HEPATITIS B): INITIAL RESULT WAS 580, REPEAT RESULT WAS 618 MIU/ML. THE SAMPLE WAS TESTED USING AN AUTOBIO ASSAY AND THE RESULT WAS NEGATIVE, AND THE COLLOIDAL GOLD RESULT WAS ALSO NEGATIVE. THE PATIENT HAD NO PREVIOUS RESULTS. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: HBSAG WAS 1389.95 IU/ML, HBEAG WAS 525.740 S/CO, HBEAB WAS 23.55 S/CO, AND HBCAB WAS 9.19 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT ANTI-HBS RESULTS FOR A MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (>/=10 MIU/ML IS PROTECTED AGAINST HEPATITIS B): INITIAL RESULT WAS 580, REPEAT RESULT WAS 618 MIU/ML. THE SAMPLE WAS TESTED USING AN AUTOBIO ASSAY AND THE RESULT WAS NEGATIVE, AND THE COLLOIDAL GOLD RESULT WAS ALSO NEGATIVE. THE PATIENT HAD NO PREVIOUS RESULTS. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: HBSAG WAS 1389.95 IU/ML, HBEAG WAS 525.740 S/CO, HBEAB WAS 23.55 S/CO, AND HBCAB WAS 9.19 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2447048 | ARCHITECT ANTI-HBS | TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) | LOM | ABBOTT IRELAND DIAGNOSTICS DIVISION | 73391FZ01 | 00380740165352 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | ARC I2000SR INST, 03M74-02, (B)(6) |