inforMED
MalfunctionCEC

ALINITY I FREE T4 REAGENT KIT

Received Sep 30, 2025 · Event occurred Aug 28, 2025

Report 3005094123-2025-00488 · MDR key 23179691

Device

Generic name

Radioimmunoassay, Free Thyroxine

Catalog number

07P70-20

Lot number

73276UD00

Product problems

  • Low Test Results
  • Low Test Results

Patient

83 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. HOWEVER, NO COMMONALITIES FOR THE COMPLAINT LOT AND ISSUE WERE IDENTIFIED. IN-HOUSE TESTING WITH A RETAINED KIT OF REAGENT LOT 73276UD00 WAS COMPLETED. TESTING MET ACCEPTANCE CRITERIA, AND THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY, LOT 73276UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I FREE T4 RESULTS FOR AN 83-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 INITIAL FREE T4 (B)(6) 2025) 1.21, REPEATED (B)(6) 2025) 1.78. HISTORICAL RESULTS: FREE T4 ((B)(6) 2025) 1.49, (B)(6) 2025) 1.3, (B)(6) 2024) 1.57, (B)(6) 2024) 1.44, (B)(6) 2024) 1.35, (B)(6) 2024) 2.72, (B)(6) 2023) 1.97, (B)(6) 2023) 1.24 AND 1.2, (B)(6) 2023) 1.34, (B)(6) 2022) 1.67 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P70 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P70, WITH 510K NUMBER K173122. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I FREE T4 RESULTS FOR AN 83-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025 INITIAL FREE T4 (B)(6) 2025) 1.21, REPEATED (B)(6) 2025) 1.78. HISTORICAL RESULTS FREE T4 (B)(6) 2025) 1.49, (B)(6) 2025) 1.3, (B)(6) 2024) 1.57, (B)(6) 2024) 1.44, (B)(6) 2024) 1.35, (B)(6) 2024) 2.72, (B)(6) 2023) 1.97, (B)(6) 2023) 1.24 AND 1.2, (B)(6) 2023) 1.34, (B)(6) 2022) 1.67 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.