ALINITY I ANTI-HCV REAGENT KIT
Report
- Report Number
- 3002809144-2025-00351
- Event Type
- Malfunction
- Date Received
- November 5, 2025
- Date of Event
- October 21, 2025
- Report Date
- December 11, 2025
- Manufacturer
- ABBOTT GMBH
- Product Code
- MZO
- UDI-DI
- 00380740169206
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PATIENT INFORMATION SECTION A1 PATIENT IDENTIFIER EXCEEDED CHARACTER LIMIT, THE FULL ID IS (B)(6). NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P06 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P05, AND 510K/PMA/BLA OF P050042. EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE COMPLAINT INVESTIGATION OF LOT 74263BE00 INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT 74263BE00. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW FOR THE LIST NUMBER DID NOT IDENTIFY ANY RELATED TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-HCV REAGENT LOT 74263BE00 WAS IDENTIFIED.
CORRECTED INFORMATION: SECTION B5 DESCRIPTION OF EVENT UPDATED DATE OF PREVIOUS HISTORICAL RESULT TO 30SEP2025. SECTION D9 UPDATED TO NO. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE CUSTOMER OBSERVED INCONSISTENT/FALSE NEGATIVE ALINITY I ANTI-HCV RESULTS AT THE CUTOFF FOR A PATIENT SAMPLE. SID (B)(6) TESTED 1.07 S/CO (REACTIVE), HARD SPUN AND RERAN ANOTHER ALINITY ANALYZER OF 0.98 S/CO (NON-REACTIVE) AND 1.02 S/CO (REACTIVE). THE FINAL RESULT OF REACTIVE. THEN, THE CUSTOMER REPEATED THE SAMPLE ON THE ORIGINAL ANALYZER WITH HARD SPUN OF 0.99 S/CO (NON-REACTIVE), 0.98 S/CO (NON-REACTIVE), 1.05 S/CO (REACTIVE). THE FINAL RESULT NON-REACTIVE. THE RESULT RELEASED AS NON-REACTIVE. PREVIOUS HISTORICAL RESULT ON (B)(6) 2025 OF 1.15 S/CO (REACTIVE). AS THE PREVIOUS HISTORY WAS REACTIVE, THE CUSTOMER'S CLINICIAN WAS EXPECTING A REACTIVE RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED INCONSISTENT/FALSE NEGATIVE ALINITY I ANTI-HCV RESULTS AT THE CUTOFF FOR A PATIENT SAMPLE. SID (B)(6), TESTED 1.07 S/CO (REACTIVE), HARD SPUN AND RERAN ANOTHER ALINITY ANALYZER OF 0.98 S/CO (NON-REACTIVE) AND 1.02 S/CO (REACTIVE). THE FINAL RESULT OF REACTIVE. THEN, THE CUSTOMER REPEATED THE SAMPLE ON THE ORIGINAL ANALYZER WITH HARD SPUN OF 0.99 S/CO (NON-REACTIVE), 0.98 S/CO (NON-REACTIVE), 1.05 S/CO (REACTIVE). THE FINAL RESULT NON-REACTIVE. THE RESULT RELEASED AS NON-REACTIVE. PREVIOUS HISTORICAL RESULT ON (B)(6) 2025 OF 1.15 S/CO (REACTIVE). AS THE PREVIOUS HISTORY WAS REACTIVE, THE CUSTOMER'S CLINICIAN WAS EXPECTING A REACTIVE RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED INCONSISTENT/FALSE NEGATIVE ALINITY I ANTI-HCV RESULTS AT THE CUTOFF FOR A PATIENT SAMPLE. SID (B)(6) TESTED 1.07 S/CO (REACTIVE), HARD SPUN AND RERAN ANOTHER ALINITY ANALYZER OF 0.98 S/CO (NON-REACTIVE) AND 1.02 S/CO (REACTIVE). THE FINAL RESULT OF REACTIVE. THEN, THE CUSTOMER REPEATED THE SAMPLE ON THE ORIGINAL ANALYZER WITH HARD SPUN OF 0.99 S/CO (NON-REACTIVE), 0.98 S/CO (NON-REACTIVE), 1.05 S/CO (REACTIVE). THE FINAL RESULT NON-REACTIVE. THE RESULT RELEASED AS NON-REACTIVE. PREVIOUS HISTORICAL RESULT ON (B)(6) 2025 OF 1.15 S/CO (REACTIVE). AS THE PREVIOUS HISTORY WAS REACTIVE, THE CUSTOMER'S CLINICIAN WAS EXPECTING A REACTIVE RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2551616 | ALINITY I ANTI-HCV REAGENT KIT | ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS | MZO | ABBOTT GMBH | 74263BE00 | 00380740169206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) |