Access Free T3 A13422Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15099590201661), received between Nov 4, 2016 and Oct 6, 2020 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Mar 15, 2023Open, Classified

   The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This introduces a risk of the positive bias not being detected by QC with the potential that clinical correlation with other thyroid function tests will be inconsistent requiring additional testing; however the clinical assessment and treatment decisions are not made in isolation on a single test result especially, in the setting of thyroid function testing. False positive test results could lead to a euthyroid patient being interpreted clinically as having elevated thyroid function (hyperthyroid) or a hypothyroid patient being within the normal range. Such misdiagnoses may lead to inappropriate treatment of a euthyroid patient with anti-thyroid medications or hypothyroid patient not getting sufficient treatment since their free T3 test result demonstrates them to be in the euthyroid range.

   Z-1419-2023 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2020High Test Results; High Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED ERRONEOUS REPRODUCIBLE ELEVATED FREE T3 (ACCESS FREE T3, PART NUMBER A13422 AND LOT NUMBER 921603) OF 12.1 PG/ML WAS GENERATED FOR ONE PATIENT ON THE LABORATORY'S DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER A71456 AND SERIAL NUMBER(B)(4)) ON (B)(6) 2020. THE PATIENT WAS DIAGNOSED AS HYPERTHYROID. ON (B)(6) 2020 THE PATIENT WAS REDRAWN AND A FREE T3 RESULT OF 9.48 PG/ML WAS OBTAINED. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THE ELEVATED FREE T3 RESULT. THE PATIENT WAS ADMINISTERED PTU (PROPYTHIOURACIL), MMI (METHIMAZOLE) AND LUGOL (DOSAGES AND DOSE INTERVALS NOT PROVIDED). THERE WAS NO FURTHER REPORT OF CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THE ELEVATED FREE T3 RESULT AND THERE WERE NO FURTHER ADVERSE PATIENT OUTCOMES REPORTED. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WERE NO REPORTS OF HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. THERE WERE NO ISSUES REPORTED WITH SAMPLE INTEGRITY. THE PATIENT WAS REDRAWN ON (B)

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10637943 ↗
• InjuryMar 14, 2017High Test Results; High Test Results

  THE CUSTOMER CONTACTED BECKMAN COULTER ON MARCH 06, 2017 TO REPORT GENERATING REPRODUCIBLE, ELEVATED FREE THYROXINE (ACCESS FREE T4) AND FREE TRIIODOTHYRONINE (ACCESS FREE T3) RESULTS FOR ONE PATIENT ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBERS (B)(4). THE CUSTOMER COULD NOT PROVIDE INFORMATION ON WHICH INSTRUMENT WAS IN USE AT THE TIME OF THIS EVENT. THE ELEVATED RESULTS DID NOT CORRELATE WITH THE REPRODUCIBLE THYROID-STIMULATING HORMONE (ACCESS TSH) RESULTS GENERATED FROM THE SAME PATIENT SAMPLES, WHICH RECOVERED WITH ONE RESULT BELOW THE ASSAY'S NORMAL REFERENCE RANGE AND ALL OTHER SAMPLES RECOVERING WITHIN THE ACCESS TSH NORMAL REFERENCE RANGE. THE ELEVATED ACCESS FREE T4 AND ACCESS FREE T3 RESULTS ALSO DID NOT CORRELATE WITH RESULTS OBTAINED ON AN ALTERNATE METHODOLOGY (DIASORIN LIAISON). ALL SEVEN SAMPLES FROM THE PATIENT GENERATED EITHER AN ELEVATED ACCESS FREE T4 RESULT, AN ELEVATED ACCESS FREE T3 RESULT OR AN ELEVATED RESULT FOR BOTH ANALYTES. ONE ACCESSTSH RESULT FOR THE PATIENT, OBTAINED ON (B)(6) 2017, RECOVERED BELOW THE ASSAY'S NORMAL REFERENCE RANGE. ALL OTHER ACCESSTSH RESULTS OBTAINED FOR THE PATIENT RECOVERED WITHIN THE ASSAY'S NORMAL REFERENCE R

  Patient problems: No Code Available

  MAUDE report 6402367 ↗
• MalfunctionNov 28, 2016High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING A FALSE HIGH ACCESS FT3 (FREE TRIIODOTHYRONINE) RESULT ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE INITIAL RESULT RECOVERED ABOVE THE ASSAY REFERENCE RANGE. THE RESULT WAS RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER RE-ANALYZED THE PATIENT'S SAMPLE USING THREE (3) DIFFERENT METHODOLOGIES, AND RECOVERED WITH LOWER RESULTS. THE SAMPLE WAS RE-ANALYZED ON AN ABBOTT ARCHITECT SYSTEM, A FUJIREBIO LUMIPULSE SYSTEM AND AN UNIDENTIFIED THIRD METHODOLOGY. THE SAMPLE WAS COLLECTED IN A SERUM SEPARATOR TUBE AND CENTRIFUGED FOR FIVE (5) MINUTES AT 3000 RPM (REVOLUTIONS PER MINUTE). THERE WAS NO REPORT OF SAMPLE INTEGRITY ISSUES. CALIBRATION, QUALITY CONTROL (QC) AND SYSTEM CHECK PARAMETERS MET ASSAY AND SYSTEM SPECIFICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6129046 ↗
• MalfunctionNov 18, 2016High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING FALSELY ELEVATED FREE TRIIODOTHYRONINE (ACCESS FREE T3) RESULTS FOR SEVERAL PATIENTS ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER NOT PROVIDED). THE CUSTOMER PROVIDED SAMPLE RESULTS FOR SEVEN (7) PATIENTS THAT INITIALLY RESULTED WITH ELEVATED ACCESS FREE T3 RESULTS ABOVE THE NORMAL REFERENCE RANGE OF THE ASSAY THAT WERE DISCORDANT TO THEIR OTHER THYROID TESTING, FREE THYROXINE (ACCESS FREE T4) AND HUMAN THYROID STIMULATING HORMONE (ACCESS HTSH) AS WELL AS TO ANOTHER METHODOLOGY. THE CUSTOMER REANALYZED THE PATIENTS' SAMPLES AGAIN ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND OBTAINED A SIMILAR, ELEVATED ACCESS FREE T3 RESULT. THE SAMPLES WERE ALSO ANALYZED ON AN ALTERNATE UNKNOWN METHODOLOGY WHICH PRODUCED LOWER, DISCORDANT RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE INITIAL, ELEVATED ACCESS FREE T3 RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WERE NO REPORTS OF CHANGE TO OR IMPACT TO PATIENT TREATMENT IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER DID NOT SUPPLY ANY DATA REGARDING SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROLS (QC), CALIBRATION CURVES OR SYSTEM CHECK REPORTS FOR REVI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6114121 ↗
• MalfunctionNov 4, 2016High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING ELEVATED FREE TRIIODOTHYRONINE (ACCESS FREE T3) RESULTS FOR THREE PATIENTS ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) THAT WERE DISCORDANT TO ONE OTHER METHODOLOGY AND THE PATIENTS' CLINICAL FILES. THE INITIAL ACCESS FREE T3 RESULTS RECOVERED ABOVE THE CUSTOMER'S NORMAL REFERENCE RANGE. THE CUSTOMER ANALYZED THE PATIENTS' SAMPLES ON ONE ALTERNATE METHODOLOGY (ABBOTT FREE T3) AND OBTAINED DISCORDANT, LOWER FREE TRIIODOTHYRONINE RESULTS. THE ACCESS FREE T3 RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THIS REPORT ADDRESSES THE RESULTS OBTAINED ON (B)(6) 2016 FOR THE PATIENT DESIGNATED AS PATIENT 2. MDR 2122870-2016-00520 ADDRESSES THE RESULTS OBTAINED ON (B)(6) 2016 FOR ONE PATIENT, (DESIGNATED AS PATIENT 1) UTILIZING A DIFFERENT LOT NUMBER OF ACCESS FREE T3 REAGENT. MDR 2122870-2016-00521 ADDRESSES THE RESULTS OBTAINED ON (B)(6) 2016 FOR TWO PATIENTS, (DESIGNATED AS PATIENT 2 AND PATIENT 3) UTILIZING A DIFFERENT LOT NUMBER OF ACCESS FREE T3 REAGENT. CALIBRATION, QC (QUALITY CONTROL), AND SYSTEM CHECK WERE PERFORMING WITHIN ASS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6078480 ↗
• MalfunctionNov 4, 2016High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING ELEVATED FREE TRIIODOTHYRONINE (ACCESS FREE T3) RESULTS FOR THREE PATIENTS ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) THAT WERE DISCORDANT TO ONE OTHER METHODOLOGY AND THE PATIENTS' CLINICAL FILES. THE INITIAL ACCESS FREE T3 RESULTS RECOVERED ABOVE THE CUSTOMER'S NORMAL REFERENCE RANGE. THE CUSTOMER ANALYZED THE PATIENTS' SAMPLES ON ONE ALTERNATE METHODOLOGY (ABBOTT FREE T3) AND OBTAINED DISCORDANT, LOWER FREE TRIIODOTHYRONINE RESULTS. THE ACCESS FREE T3 RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THIS REPORT ADDRESSES THE RESULTS OBTAINED ON (B)(6) 2016 FOR TWO PATIENTS, (DESIGNATED AS PATIENT 2 AND PATIENT 3). MDR 2122870-2016-00520 ADDRESSES THE RESULTS OBTAINED ON (B)(6) 2016 FOR ONE PATIENT, (DESIGNATED AS PATIENT 1). MDR 2122870-2016-00522 ADDRESSES THE RESULTS OBTAINED ON (B)(6) 2016 UTILIZING A DIFFERENT LOT NUMBER OF ACCESS FREE T3 REAGENT FOR THE PATIENT DESIGNATED AS PATIENT 2. CALIBRATION, QC (QUALITY CONTROL), AND SYSTEM CHECK WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6078478 ↗
• MalfunctionNov 4, 2016High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING ELEVATED FREE TRIIODOTHYRONINE (ACCESS FREE T3) RESULTS FOR THREE PATIENTS ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) THAT WERE DISCORDANT TO ONE OTHER METHODOLOGY AND THE PATIENTS' CLINICAL FILES. THE INITIAL ACCESS FREE T3 RESULTS RECOVERED ABOVE THE CUSTOMER'S NORMAL REFERENCE RANGE. THE CUSTOMER ANALYZED THE PATIENTS' SAMPLES ON ONE ALTERNATE METHODOLOGY (ABBOTT FREE T3) AND OBTAINED DISCORDANT, LOWER FREE TRIIODOTHYRONINE RESULTS. THE ACCESS FREE T3 RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THIS REPORT ADDRESSES THE RESULTS OBTAINED ON (B)(6) 2016 FOR ONE PATIENT, (DESIGNATED AS PATIENT 1). MDR 2122870-2016-00521 ADDRESSES THE RESULTS OBTAINED ON (B)(6) 2016 FOR TWO PATIENTS, (DESIGNATED AS PATIENT 2 AND PATIENT 3). MDR 2122870-2016-00522 ADDRESSES THE RESULTS OBTAINED ON (B)(6) 2016 UTILIZING A DIFFERENT LOT NUMBER OF ACCESS FREE T3 REAGENT FOR THE PATIENT DESIGNATED AS PATIENT 2. CALIBRATION, QC (QUALITY CONTROL), AND SYSTEM CHECK WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6078477 ↗