ALINITY I TOXO IGM REAGENT KIT
Received Jun 25, 2026 · Event occurred May 22, 2026
Report 3002809144-2026-00169 · MDR key 25619319
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Manufacturer
Abbott GmbhCatalog number
07P47-22
Lot number
83430BE00
Product problems
- False Positive Result
Patient
20 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOXO IGM RESULTS FOR A 20-YEAR-OLD FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: TOXO IGM RESULTS WITH SID (B)(6) = 4.90 INDEX, 4.80 INDEX, 4.47 INDEX NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P47-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P47-40 / 45 WITH 510K/PMA/BLA NUMBER K233932. 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.