Access Total T3 33830Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590227210), received between May 14, 2024 and May 14, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “High Test Results” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024High Test Results; High Test Results

  ON (B)(6) 2024 THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED TOTAL T3 RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(6). THE TOTAL T3 CUSTOMER REFERENCE RANGES ARE 0.87-1.78 NG/ML. ON (B)(6) 2024, ONE SAMPLE WAS TESTED WITH A RESULT AT 1.95 NG/ML. THE SAMPLE WAS TESTED ON THE ROCHE ANALYZER WITH A TOTAL T3 RESULT AT 0.96 (NO UNIT PROVIDED). THE CUSTOMER REPORTED A DELAY IN PATIENT TREATMENT. THE CUSTOMER REPORTED THAT DOCTOR LOOKS AT TEST RESULTS AND PRESCRIBES MEDICATION ON THE SAME DAY. DUE TO THE QUESTIONED RESULTS, PATIENT SAMPLES ARE SENT TO AN EXTERNAL TESTING LABORATORY AND THE RESULTS ARE PROVIDED ONE DAY LATER. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON 20MAR2024 WITH REAGENT LOT 338710 AND CALIBRATOR LOT 338395. NO QUALITY CONTROL DATA WAS PROVIDED. SERVICE WAS DISPATCHED. FIELD SERVICE ENGINEER (FSE) CHANGED REAGENT AND CALIBRATION AND USED HETEROPHILE BLOCKING TUBES BUT THE RESULTS WERE UNCHANGED. NO ISSUES WITH SAMPLES INTEGRITY WERE REPORTED BY THE CUSTOMER. NOTE: THE CUSTOMER REPORTED THAT THE ACCESS FREE T4 RESULTS FOR THIS PATIENT WERE ALSO QUESTIONED. A SECOND M

  Patient problems: Insufficient Information

  MAUDE report 19309697 ↗
• InjuryMay 14, 2024High Test Results; High Test Results

  ON (B)(6) 2024 THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED TOTAL T3 RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(6). THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (THE TOTAL T3 CUSTOMER REFERENCE RANGES ARE 0.87-1.78 NG/ML). THE FIRST QUESTIONED SAMPLE TOTAL T3 RESULT FOR THIS PATIENT WAS 2.37 NG/ML ON (B)(6) 2023. THIS SAMPLE WAS TESTED ON AN ALTERNATE INSTRUMENT WITH A RESULT AT 0.64 (UNIT NOT PROVIDED). SAMPLE 2 TOTAL T3 RESULT WAS 3.05 NG/ML ON (B)(60 2024. THIS SAMPLE WAS TESTED ON AN ALTERNATE INSTRUMENT WITH A RESULT AT 0.84 (UNIT NOT PROVIDED). SAMPLE 3 TOTAL T3 RESULT WAS 2.43 NG/ML ON (B)(6) 2024. THIS SAMPLE WAS TESTED ON AN ALTERNATE INSTRUMENT WITH A RESULT AT 0.37 (UNIT NOT PROVIDED). SAMPLE 4 TOTAL T3 RESULT WAS 1.86 NG/ML ON (B)(6) 2024. THIS SAMPLE 4 WAS TESTED USING HETEROPHILE BLOCKING TUBE WITH A TOTAL T3 RESULT AT 1.89 NG/ML. THIS SAMPLE WAS ALSO TESTED ON AN ALTERNATE INSTRUMENT WITH A RESULT AT 0.52 (UNIT NOT PROVIDED). THE SAMPLE 5 RESULT WAS NOT QUESTIONED: TOTAL T3 RESULT WAS 0.8 NG/ML ON (B)(6) 2024. THIS SAMPLE 5 WAS TESTED ON AN ALTERNATE INSTRUMENT WITH A RESULT AT 0.75 (UNIT NOT PROVIDED).

  Patient problems: Insufficient Information

  MAUDE report 19309599 ↗