Access Free T4 33880Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 15099590225834), received between Mar 14, 2017 and May 14, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “High Test Results” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

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

  ON 01MAY2024 THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED FREE T4 RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(6)). THE FREE T4 CUSTOMER REFERENCE RANGES ARE 0.6-1.6 NG/DL. ON (B)(6) 2024, TWO SAMPLES FROM ONE PATIENT WERE TESTED ON TWO DIFFERENT ACCESS 2. NO FURTHER INFORMATION WAS PROVIDED. - FIRST ANALYZER: ACCESS FREE T4 RESULT AT 2.70 NG/DL. - SECOND ANALYZER: ACCESS FREE T4 RESULT AT 2.56 NG/DL. ONE SAMPLE WAS TESTED ON THE ROCHE ANALYZER WITH A FREE T4 RESULT AT 1.66 (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

  Patient problems: Insufficient Information

  MAUDE report 19309705 ↗
• InjuryMay 14, 2024High Test Results; High Test Results

  ON (B)(6) 2024 THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED FREE T4 RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(6). THE CUSTOMER PROVIDED THE FOLLOWING FREE T4 RESULTS (THE FREE T4 CUSTOMER REFERENCE RANGES ARE 0.6-1.6 NG/DL). THE FIRST QUESTIONED SAMPLE FREE T4 RESULT FOR THIS PATIENT WAS 4.8 NG/DL ON (B)(6) 2023. THIS SAMPLE WAS TESTED ON AN ALTERNATE INSTRUMENT WITH A RESULT AT 1.5 (UNIT NOT PROVIDED). SAMPLE 2 FREE T4 RESULT WAS 2.85 NG/DL ON (B)(6) 2024. THIS SAMPLE WAS TESTED ON AN ALTERNATE INSTRUMENT WITH A RESULT AT 0.91 (UNIT NOT PROVIDED). SAMPLE 3 FREE T4 RESULT WAS 2.29 NG/DL ON (B)(6) 2024. THIS SAMPLE WAS TESTED ON AN ALTERNATE INSTRUMENT WITH A RESULT AT 0.63 (UNIT NOT PROVIDED). SAMPLE 4 FREE T4 RESULT WAS 1.66 NG/DL ON (B)(6) 2024. THIS SAMPLE 4 WAS TESTED USING HETEROPHILE BLOCKING TUBE WITH A FREE T4 RESULT AT 2.1 NG/DL. THIS SAMPLE WAS ALSO TESTED ON AN ALTERNATE INSTRUMENT WITH A RESULT AT 0.61 (UNIT NOT PROVIDED). SAMPLE 5 FREE T4 RESULT WAS 1.01 NG/DL ON (B)(6) 2024. THIS SAMPLE 5 WAS TESTED ON AN ALTERNATE INSTRUMENT WITH A RESULT AT 1.45 (UNIT NOT PROVIDED). SAMPLE 6 FREE T4 RESULT WAS 4.94 NG

  Patient problems: Insufficient Information

  MAUDE report 19309561 ↗
• InjuryApr 4, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING ERRONEOUS LOW FREE T4 (ACCESS FREE T4, PART NUMBER 33880 AND LOT NUMBER 339067) RESULTS ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(6)) FOR ONE PATIENT. THE ERRONEOUS LOW FREE T4 RESULT WAS RELEASED FROM THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT HAD A SURGERY SCHEDULED WHICH WAS DELAYED DUE TO THE LOW FREE T4 RESULTS. THERE WAS NO FURTHER REPORT OF INJURY OR CHANGE TO PATIENT MANAGEMENT. INITIAL RESULTS OF 0.32 AND 0.39 NG/DL WERE OBTAINED. THE SAME SAMPLE WAS SENT TO ANOTHER LABORATORY USING AN ALTERNATE METHODOLOGY AND THE RESULTS WERE 1.0 AND 1.83 NG/DL. THE CUSTOMER STATED THE ALTERNATE LABORATORY'S METHODOLOGY WAS ECLIA; HOWEVER, THE CUSTOMER DID NOT KNOW WHAT INSTRUMENT OR PLATFORM WAS USED. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED. SYSTEM PERFORMANCE INDICATORS HAVE BEEN PASSING WITHIN SPECIFICATION. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER.

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

  MAUDE report 19047404 ↗
• InjuryMar 31, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A QUESTIONED HIGH FREE T4 (ACCESS FREE T4, PART NUMBER 33880 AND LOT NUMBER 125435) WAS GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB. THERE WAS A CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE CUSTOMER-PROVIDED INFORMATION INDICATED THE PATIENT'S SYNTHROID DOSE WAS DECREASED FROM 175 UG TO 150 UG. NO REPORT OF ADDITIONAL CHANGES TO PATIENT TREATMENT OR MANAGEMENT WERE PROVIDED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER REPORTED THEY PREVIOUSLY HAD INVESTIGATIVE INTERFERENCE TESTING PERFORMED BY BECKMAN COULTER FOR THE PATIENT IN THIS EVENT. THE CUSTOMER REPORTED THE PATIENT HAD A HISTORY OF TSH3 VALUE OF 0.31 UIU/ML AND FREE T4 VALUE OF 1.7 NG/DL. INVESTIGATOR REVIEW OF HISTORICAL DATA SHOWS THE SAMPLE FROM (B)(6) 2021 WAS RETURNED

  Patient problems: Insufficient Information

  MAUDE report 13966015 ↗
• InjuryNov 22, 2021High Test Results; High Test Results

  ON 25OCT2021 THE CUSTOMER REPORTED THAT ON (B)(6) 2021, A QUESTIONED HIGH FREE T4 (ACCESS FREE T4, PART NUMBER 33880 AND LOT NUMBER 124928) WAS GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(6)) FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER ALSO PROVIDED PREVIOUS FREE T4 RESULTS WHICH HAD BEEN GENERATED FOR THIS PATIENT; HOWEVER, THE CUSTOMER DID NOT INDICATE WHETHER THE PREVIOUS FREE T4 RESULTS WERE QUESTIONED. THERE WAS A CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE CUSTOMER-PROVIDED INFORMATION INDICATED THE PATIENT'S SYNTHROID DOSE WAS DECREASED FROM 200 UG TO 175 UG. NO REPORT OF ADDITIONAL CHANGES TO PATIENT TREATMENT OR MANAGEMENT WERE PROVIDED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. SAMPLE WAS COLLECTED IN A LITHIUM HEPARINIZED PLASMA GEL SEPARATOR TUBE, CENTRIFUGED FOR 5 MINUTES AT 5000 REVOLUTI

  Patient problems: Insufficient Information

  MAUDE report 12853056 ↗
• InjurySep 24, 2021Low Test Results; Low Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED QUESTIONED LOW FREE T4 (ACCESS FREE T4, PART NUMBER 33880 AND LOT NUMBER 124403) WERE GENERATED ON THE CUSTOMER'S DXI (DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) FOR AN UNDISCLOSED NUMBER OF PATIENTS. CUSTOMER PROVIDED A LIST OF RESULTS; HOWEVER, CUSTOMER DID NOT INDICATE WHICH RESULTS WERE CONSIDERED QUESTIONED LOW AND ALSO DID NOT INDICATE WHICH RESULTS WERE ASSOCIATED WITH CHANGE TO PATIENT MANAGEMENT. THE LOW FREE T4 RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER REPORTED THEY SENT SAMPLES TO A REFERENCE LAB TO BE TESTED USING THE REFERENCE LAB'S ACCESS 2. CUSTOMER REPORTED THEY CONSIDERED THESE RESULT TO BE SIMILAR TO THE RESULTS GENERATED ON THE CUSTOMER'S DXI. THERE WAS A REPORT OF A CHANGE TO PATIENT MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED THE PHYSICIAN WAS DELAYING TREATMENT FOR THE PATIENTS DUE TO THE QUESTIONED LOW FREE T4 RESULTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING TREATMENT OF THE PATIENTS. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRAT

  Patient problems: Insufficient Information

  MAUDE report 12527237 ↗
• InjurySep 24, 2021Low Test Results; Low Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED QUESTIONED LOW FREE T4 (ACCESS FREE T4, PART NUMBER 33880 AND LOT NUMBER 124082) WERE GENERATED ON THE CUSTOMER'S DXI (DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER 608813) FOR AN UNDISCLOSED NUMBER OF PATIENTS. CUSTOMER PROVIDED A LIST OF RESULTS; HOWEVER, CUSTOMER DID NOT INDICATE WHICH RESULTS WERE CONSIDERED QUESTIONED LOW AND ALSO DID NOT INDICATE WHICH RESULTS WERE ASSOCIATED WITH CHANGE TO PATIENT MANAGEMENT. THE LOW FREE T4 RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER REPORTED THEY SENT SAMPLES TO A REFERENCE LAB TO BE TESTED USING THE REFERENCE LAB'S ACCESS 2. CUSTOMER REPORTED THEY CONSIDERED THESE RESULT TO BE SIMILAR TO THE RESULTS GENERATED ON THE CUSTOMER'S DXI. THERE WAS A REPORT OF A CHANGE TO PATIENT MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED THE PHYSICIAN WAS DELAYING TREATMENT FOR THE PATIENTS DUE TO THE QUESTIONED LOW FREE T4 RESULTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING TREATMENT OF THE PATIENTS. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRAT

  Patient problems: Insufficient Information

  MAUDE report 12527199 ↗
• InjurySep 1, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING FALSE HIGH ACCESS FREE T4 (PART NUMBER 33880, LOT NUMBER 922166) PATIENT RESULTS WHEN LOADING A NEW REAGENT PACK INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (SERIAL NUMBER (B)(4)). ALL FREE T4 PATIENTS RESULTS WERE DISCORDANT WITH OTHER THYROID FUNCTION-ASSOCIATED ASSAYS. NO DATA WAS PROVIDED. CUSTOMER STATED THAT EIGHT (8) PATIENT RESULTS WERE ALREADY RELEASED OUT OF THE LABORATORY. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED THAT ONE PATIENT RECEIVED INAPPROPRIATE TREATMENT DUE TO THE ERRONEOUSLY HIGH FREE T4 RESULT OBTAINED. NO FURTHER INFORMATION WAS PROVIDED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. PER CUSTOMER VERBAL'S REPORT, SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER PERFORMED A NEW CALIBRATION WITH THE SUSPECTED PACK AND CALIBRATION FAILED. PER CUSTOMER THE RLU (RELATIVE LIGHT UNIT) VALUE OF POINT S0 WAS SIGNIFICANTLY DIFFERENT FROM THE PREVIOUS CALIBRATION. QUALITY CONTROL WAS NOT PERFORMED WITH THE NEW REAGENT PACK. A BECKMAN COULTER FIELD S

  Patient problems: Insufficient Information

  MAUDE report 12406208 ↗
• InjuryJul 16, 2019Low Test Results; Low Test Results

  ON JUNE 19TH, 2019, THE CUSTOMER REPORTED THAT ON (B)(6) 2016, A QUESTIONED LOW ACCESS FREE T4 RESULT OF 0.8 (UNITS NOT PROVIDED) HAD BEEN GENERATED ON THE CUSTOMER¿S UNICEL DXI 600 IMMUNOASSAY ANALYZER (PART NUMBER A71460 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT SAMPLE. THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT PROVIDE THE REFERENCE RANGE. THE CUSTOMER REPORTED A CHANGE TO PATIENT TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE CUSTOMER NOTED THAT TOO MUCH THYROID WAS GIVEN. ADDITIONAL DETAILS OF THIS CHANGE TO PATIENT TREATMENT WERE NOT PROVIDED. NO REPORT OF ADDITIONAL CHANGES TO PATIENT MANAGEMENT WERE PROVIDED. QUALITY CONTROL RESULTS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. OTHER SYSTEM PERFORMANCE INDICATOR INFORMATION SUCH AS SYSTEM CHECKS OR CALIBRATIONS WERE NOT SUPPLIED. THERE WERE NO ERRORS OR EVENTS REPORTED ON THE UNICEL DXI 600 IMMUNOASSAY SYSTEM AT THE TIME OF THE EVENT. THE SAMPLE WAS CENTRIFUGED AT 3000 RPM FOR 8 MINUTES. THE CUSTOMER NOTED THAT THE SAMPLE WAS A BD RST TUBE WITH THROMBIN-BASED CLOT ACTIVATOR AND POLYMER GEL. NO OTHER SAMPLE PROCESSING INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8794536 ↗
• InjuryJul 16, 2019Low Test Results; Low Test Results

  ON JUNE 19TH, 2019, THE CUSTOMER REPORTED THAT ON (B)(6) 2019, A QUESTIONED LOW ACCESS FREE T4 RESULT OF 0.9 (UNITS NOT PROVIDED) HAD BEEN GENERATED ON THE CUSTOMER¿S UNICEL DXI 600 IMMUNOASSAY ANALYZER (PART NUMBER A71460 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT SAMPLE. THE RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER ALSO REPORTED THAT THERE WERE PREVIOUS DATES THAT THE PATIENT HAD FREE T4 TESTED: ON (B)(6) 2018, THE PATIENT HAD A FREE T4 RESULT OF 1 (UNITS NOT PROVIDED) AND ON (B)(6) 2019, THE PATIENT HAD A FREE T4 RESULT OF 1 (UNITS NOT PROVIDED). THE CUSTOMER DID NOT PROVIDE THE REFERENCE RANGE. THE CUSTOMER REPORTED A CHANGE TO PATIENT TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. DETAILS OF THIS CHANGE TO PATIENT TREATMENT WERE NOT PROVIDED. NO REPORT OF ADDITIONAL CHANGES TO PATIENT MANAGEMENT WERE PROVIDED. QUALITY CONTROL RESULTS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. OTHER SYSTEM PERFORMANCE INDICATOR INFORMATION SUCH AS SYSTEM CHECKS OR CALIBRATIONS WERE NOT SUPPLIED. THERE WERE NO ERRORS OR EVENTS REPORTED ON THE UNICEL DXI 600 IMMUNOASSAY SYSTEM AT THE TIME OF THE EVENT. THE SAMPLE WAS CENTRIFUGED AT 3000 RPM FOR 8 MINUTES. THE CUS

  Patient problems: No Code Available

  MAUDE report 8794382 ↗
• InjuryAug 25, 2017Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING A LOW FREE THYROXINE (ACCESS FREE T4) RESULT FOR ONE (1) PATIENT INVOLVING ONE OF TWO UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMS (SERIAL (B)(4)). THE CUSTOMER COULD NOT PROVIDE INFORMATION ON WHICH OF THE TWO ANALYZERS WERE IN USE FOR THIS EVENT. THE LOW ACCESS FREE T4 RESULT WAS RELEASED FROM THE LABORATORY. A PHYSICIAN INDICATED THERE WAS A CHANGE MADE TO PATIENT MEDICATION, FOR ONE PATIENT; HOWEVER, NO FURTHER DETAILS ARE AVAILABLE. THE CUSTOMER PROVIDED ADDITIONAL QUESTIONED LOW ACCESS FREE T4 RESULTS FOR TWENTY SIX (26) PATIENT SAMPLES, IT IS UNKNOWN WHICH PATIENT WAS AFFECTED BY THE CHANGE TO MEDICATION. QUALITY CONTROL (QC), CALIBRATION AND SYSTEM CHECK WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE PATIENT SAMPLE WAS SERUM, COLLECTED IN A SERUM SEPARATOR TUBE WITH GEL. THE CUSTOMER DID NOT PROVIDE ADDITIONAL SAMPLE COLLECTION AND HANDLING INFORMATION SUCH AS CENTRIFUGATION SPEED AND TIME. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FSE WAS DISPATCHED TO EVALUAT

  Patient problems: No Code Available

  MAUDE report 6820769 ↗
• 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 6402373 ↗