ALINITY I TOXO IGG REAGENT KIT
Report
- Report Number
- 3002809144-2025-00281
- Event Type
- Malfunction
- Date Received
- September 5, 2025
- Date of Event
- August 16, 2025
- Report Date
- September 15, 2025
- Manufacturer
- ABBOTT GMBH
- Product Code
- LGD
- UDI-DI
- 00380740131258
- PMA / PMN Number
- K210596
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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 7P45-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P45-40/-45, WITH 510K/PMA/BLA NUMBER K210596.
THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, FIELD DATA AND DEVICE HISTORY RECORD REVIEW OF THE ALINITY I TOXO IGG REAGENT LOT 71074BE00. DATA REVIEW OF 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 71074BE00. HISTORICAL PERFORMANCE OF THE ALINITY I TOXO IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED VIA ABBOTTLINK FROM CUSTOMERS WORLDWIDE. THE MEDIAN POPULATION RESULT FOR THE COMPLAINT LOT(S) ARE WITHIN ESTABLISHED LIMITS, INDICATING THAT THE LOT(S) ARE PERFORMING ACCEPTABLY IN THE FIELD. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT(S) AND COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I TOXO IGG REAGENT, LOT 71074BE00.
THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I TOXO IGG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE SERIAL NUMBER (B)(6) FOR ONE PREGNANT FEMALE PATIENT WHO HAS A HISTORY OF BEING NEGATIVE FOR TOXO IGG. THE SAMPLE WAS REPEATED WITH NONREACTIVE RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL ALINITY TOXO IGG SID (B)(6) RESULT PROCESSED ON (B)(6) 2025 = 7.0 IU/ML REPEATED ON (B)(6) 2025 = 0.10 IU/ML. TOXO IGG PROCESSED AT ANOTHER LABORATORY (METHOD UNKNOWN) = NEGATIVE. TOXO G AVIDITY TEST PROCESSED AT ANOTHER LABORATORY = NEGATIVE. TOXO IGM = NEGATIVE. ALINITY TOXO IGG REFERENCE RANGE: = 3.0 IU/ML REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I TOXO IGG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE SERIAL NUMBER (B)(6) FOR ONE PREGNANT FEMALE PATIENT WHO HAS A HISTORY OF BEING NEGATIVE FOR TOXO IGG. THE SAMPLE WAS REPEATED WITH NONREACTIVE RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL ALINITY TOXO IGG SID (B)(6) RESULT PROCESSED ON (B)(6) 2025 = 7.0 IU/ML REPEATED ON (B)(6) 2025 = 0.10 IU/ML. TOXO IGG PROCESSED AT ANOTHER LABORATORY (METHOD UNKNOWN) = NEGATIVE. TOXO G AVIDITY TEST PROCESSED AT ANOTHER LABORATORY = NEGATIVE. TOXO IGM = NEGATIVE. ALINITY TOXO IGG REFERENCE RANGE: = 3.0 IU/ML REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2131813 | ALINITY I TOXO IGG REAGENT KIT | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | LGD | ABBOTT GMBH | 71074BE00 | 00380740131258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6). |