ALINITY I TOXO IGG REAGENT KIT
Report
- Report Number
- 3002809144-2025-00232
- Event Type
- Malfunction
- Date Received
- July 15, 2025
- Date of Event
- July 1, 2025
- Report Date
- September 10, 2025
- Manufacturer
- ABBOTT GMBH
- Product Code
- LGD
- UDI-DI
- 00380740131265
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN EVALUATION IS IN PROCESS. A FINAL 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: 07P45-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 07P45-45, AND A 510K/PMA/BLA NUMBER OF K210596.
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW, AND IN-HOUSE TESTING. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I TOXO IGG 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: 71075BE00. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCE'S, POTENTIAL NON-CONFORMANCE'S, OR DEVIATIONS WITH LOT: 71075BE00. THE OVERALL PERFORMANCE OF ALINITY I TOXO IGG REAGENT WAS REVIEWED USING WORLDWIDE FIELD DATA. THE PATIENT MEDIAN VALUES FOR THE COMPLAINT LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED. ALL SPECIFICATIONS WERE MET, AND NO FALSE REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I TOXO IGG REAGENT KIT FOR LOT NUMBER: 71075BE00 WAS IDENTIFIED.
THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I TOXO IGG RESULT FOR A FEMALE PATIENT SAMPLE THAT IS 35 WEEKS PREGNANT THAT DID NOT MATCH THE PATIENT¿S HISTORY. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE < 1.6 IU/ML NONREACTIVE; 1.6 - < 3.0 IU/ML GRAY ZONE; >/ = 3.0 IU/ML REACTIVE): ON (B)(6) 2025: SAMPLE ID: (B)(6) INITIAL RESULT = 7.107 IU/ML, REPEAT RESULT ON ANOTHER INSTRUMENT = 0.136 IU/ML. THE SAMPLE WAS REPEATED, AND RESULT WAS NEGATIVE, REPEATED ON ANOTHER ANALYZER AND RESULT WAS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I TOXO IGG RESULT FOR A FEMALE PATIENT SAMPLE THAT IS 35 WEEKS PREGNANT THAT DID NOT MATCH THE PATIENT¿S HISTORY. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE < 1.6 IU/ML NONREACTIVE; 1.6 - < 3.0 IU/ML GRAY ZONE; >/ = 3.0 IU/ML REACTIVE): ON (B)(6) 2025: SAMPLE ID: (B)(6) INITIAL RESULT = 7.107 IU/ML, REPEAT RESULT ON ANOTHER INSTRUMENT = 0.136 IU/ML. THE SAMPLE WAS REPEATED, AND RESULT WAS NEGATIVE, REPEATED ON ANOTHER ANALYZER AND RESULT WAS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137806 | ALINITY I TOXO IGG REAGENT KIT | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | LGD | ABBOTT GMBH | 71075BE00 | 00380740131265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | ALNTY I PROCESSING MODU, 03R65-01, (B)(6). |