Access TSH (3rd IS) B63284Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15099590671495), received between Sep 21, 2017 and Sep 30, 2026 — classified as 7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• InjurySep 30, 2026High Test Results

  The customer reported questioning elevated Access TSH (3rd IS) results for one patient involving the laboratory's UniCel DxI 800 Access Immunoassay Analyzer (Serial Number (b)(6)). The customer reported that the Access TSH results were discordant with the Roche cobas results.The patient was draw on (b)(6) 2026 and sample was kept refrigerated until testing on (b)(6) 2026. The Access result for TSH was 17.01 uIU/mL.On (b)(6) 2026, the patient was recollected and tested on Roche Cobas with a sample result at 3.75 uIU/mL. On (b)(6) 2026, the initial sample was retested with a similar Access result of 17.17 uIU/mL.The patient was redrawn on (b)(6) 2026, and tested on (b)(6) 2026 with an Access result of 7.27 uIU/mL, repeated at 7.25 uIU/mL on (b)(6) 2026. These results were obtained after the patient had been taking the medication for approximately 30 days.The patient had no documented history of hypothyroidism. On (b)(6), the physician prescribed 25 µg of Synthroid. No additional adverse patient impact was reported.No hardware errors and other assay issues were reported in conjunction with this event. Per originator's verbal report, System performance indicators were passing within sp

  Patient problems: Insufficient Information

  MAUDE report 50946406 ↗
• InjuryJul 8, 2024High Test Results; High Test Results

  CUSTOMER REPORTED OBTAINING FALSE HIGH ACCESS TSH (3RD IS) PATIENT RESULTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(6). THE NUMBER OF PATIENTS IMPACTED WAS NOT SPECIFIED. NO DATA WAS PROVIDED. PER CUSTOMER VERBAL REPORT, THE ACCESS TSH PATIENT RESULTS WERE DISCORDANT WITH AN ALTERNATE METHODOLOGY (ROCHE PLATFORM WITH LOWER RESULTS) AND CLINICAL EXPECTATIONS. THERE WAS A REPORT OF DELAY TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE FALSE HIGH TSH RESULTS AFFECTED THE PROCESS OF IN VITRO FERTILIZATION (IVF) PATIENTS. THE NORMAL CYCLE FOR IVF PATIENTS IS FIRST SEX HORMONES AND TSH TESTING. IF THE TSH RESULT IS LESS THAN 4 MU/L, OVULATION INDUCTION IS PERFORMED. THE CUSTOMER REPORTED THAT IF THE TSH RESULT IS MORE THAN 4 MU/L, THERE IS A POSSIBILITY OF HYPOTHYROIDISM IN PREGNANCY AND IN ORDER TO AVOID IT, WHICH ALSO COULD LEAD TO MISCARRIAGE, THE IVF PROCESS IS SUSPENDED. NO FURTHER INFORMATION WAS PROVIDED. NO HARDWARE ERRORS AND OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE NOT PROVIDED FOR REV

  Patient problems: Insufficient Information

  MAUDE report 19690866 ↗
• InjuryOct 3, 2023High Test Results; High Test Results

  ON 13 SEP 2023, THE CUSTOMER REPORTED OBTAINING QUESTIONED TSH (ACCESS TSH (3RD IS), PART NUMBER B63284 AND LOT NUMBER 337248) FOR ONE PATIENT. THE CUSTOMER REPORTED OBTAINING QUESTIONED TSH RESULTS ACROSS SEVERAL MONTHS BEGINNING IN MAY 2023. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THIS EVENT. THE PATIENT WAS ON LEVOTHYROXINE. THE MEDICATION DOSAGE WAS INCREASED TO 75 MCG AFTER THE FIRST TSH RESULT OBTAINED ON (B)(6) 2023. AFTER THE SECOND TSH RESULT OBTAINED ON (B)(6) 2023, THE MEDICATION DOSAGE WAS INCREASED TO 100 MCG. ON 12JUL2023, THE PHYSICIAN BEGAN TO QUESTION RESULTS AND DID NOT INCREASE THE DOSAGE FURTHER. THERE WAS NO FURTHER REPORT OF CHANGE TO PATIENT TREATMENT OR INJURY TO THE PATIENT IN CONNECTION WITH THIS EVENT. PATIENT TSH RESULTS WERE REPORTED TO BE DISCORDANT TO THE PATIENT'S CLINICAL FILE. THE PATIENT WAS UNDERGOING TREATMENT THAT SHOULD SEE TSH VALUES GO DOWN OVER COURSE OF TREATMENT. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES 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 W

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

  MAUDE report 17865305 ↗
• InjuryFeb 7, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT ON (B)(6) 2023 AN ERRONEOUS LOW TSH RESULT (ACCESS TSH, 3RD IS, PART NUMBER B63284 AND LOT NUMBER 234374) WAS GENERATED ON THE CUSTOMER'S ACCESS (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4). THE LOW TSH RESULT OF 0.068 UIU/ML RELEASED FROM THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE CLINICIAN STARTED A TREATMENT (TREATMENT DETAILS INCLUDING MEDICATION(S) AND DOSAGES NOT PROVIDED) FOR THE PATIENT. ANOTHER SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2023 AND WAS TESTED FOR TSH ON AN ALTERNATE PLATFORM (PLATFORM INFORMATION NOT PROVIDED); A RESULT OF 3.177 UIU/ML WAS OBTAINED. THERE WAS NO INFORMATION PROVIDED REGARDING POSSIBLE REPEAT TESTING OF THE ORIGINAL SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2023. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER'S BIO-RAD LEVEL 1 QC WAS OUTSIDE LOW OF THE 3SD RANGES ON (B)(6) 2023, THEN PASSED ON (B)(6) 2023. THERE WAS NO REPORT OF HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS AT THE TIME OF THE EVENT. SAMPLE COLL

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

  MAUDE report 16315370 ↗
• InjuryAug 13, 2019High Test Results; High Test Results

  ON JULY 31, 2019 THE CUSTOMER REPORTED THAT ON (B)(6) 2019 AN ELEVATED TSH RESULT WAS GENERATED ON THE CUSTOMER'S UNICEL DXI 800 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4) FOR ONE PATIENT SAMPLE. THE CUSTOMER STATED THAT THE RESULT OF "AROUND 27 UIU/ML" (VERBAL REPORT) WAS RELEASED FROM THE LABORATORY AND WAS LATER QUESTIONED BY A PHYSICIAN. THE CUSTOMER REPORTED THAT THE PHYSICIAN ADJUSTED THE PATIENT'S MEDICATION DUE TO THE ELEVATED RESULT; HOWEVER, DETAILS ABOUT MEDICATION OR DOSAGE WERE NOT PROVIDED. THE CUSTOMER REPORTED REPEAT TESTING OF THE SAMPLE WAS NOT POSSIBLE AS THE SAMPLE WAS DISCARDED. CUSTOMER REPORTED THAT THE PHYSICIAN QUESTIONED THE RESULT BECAUSE IT WAS INCONSISTENT WITH HISTORICAL RESULTS. CUSTOMER REPORTED PREVIOUS TSH RESULT FOR PATIENT GENERATED IN (B)(6) 2019 WAS 0.17 UIU/ML; CUSTOMER REPORTED A REPEAT TSH TEST OF THE PATIENT PERFORMED ON (B)(6) 2019 GAVE A RESULT OF 0.17 UIU/ML. CUSTOMER DID NOT PROVIDE REFERENCE RANGES. BECKMAN COULTER TSH REFERENCE RANGE IS 0.45 UIU/ML - 5.33 UIU/ML. CALIBRATION AND QUALITY CONTROL WERE PASSING AT THE TIME OF THE EVENT. CUSTOMER REPORTED SYSTEM CHECK PERFORMED ON (B)(6) 2019 WAS WITHIN SPECIFICATIONS. NO SAMPLE COLLECTION

  Patient problems: No Code Available

  MAUDE report 8888182 ↗
• InjuryFeb 1, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE ELEVATED TSH (ACCESS TSH) RESULTS FOR ONE PATIENT GENERATED ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, SERIAL NUMBER (B)(4). THERE WAS A REPORT OF A CHANGE IN PATIENT TREATMENT DUE TO THE FALSELY ELEVATED ACCESS TSH RESULTS. THE PATIENT WAS ADMINISTERED THYROXINE. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY. CALIBRATION AND QUALITY CONTROL WERE WITHIN RANGE AT THE TIME OF THE EVENT.

  Patient problems: No Code Available

  MAUDE report 8299443 ↗
• InjurySep 21, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING ELEVATED THYROID-STIMULATING HORMONE (ACCESS TSH (3RD IS)) RESULTS ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM PORTION TO THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMS (SERIAL (B)(4)) FOR ONE PATIENT. THERE WAS A CHANGE IN THE PATIENT'S TREATMENT AS THE PATIENT'S MEDICATION WAS ADJUSTED DUE TO THE ELEVATED ACCESS TSH (3RD IS) RESULTS. THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL DETAILS. THE PATIENT HAD A PREVIOUS ACCESS TSH (3RD IS) RESULT OF 1.65 IU/ML, WITHIN THE CUSTOMER'S REFERENCE RANGE OF 0.34-5.60 IU/ML. THIS TESTING WAS PERFORMED ON (B)(6) 2017 USING THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM PORTION TO THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMS SERIAL (B)(4). THE PATIENT HAD A SAMPLE TESTED AT (B)(6) ON A ROCHE E170 ANALYZER ON (B)(6) 2017; THE RESULT WAS 2.580 IU/ML. THE REFERENCE RANGE IN USE WAS NOT PROVIDED. ON (B)(6) 2017, THE PATIENT HAD ANOTHER SAMPLE COLLECTED; THE ACCESS TSH (3RD IS) RESULT WAS 15.85 IU/ML. ON (B)(6) 2017, THE PATIENT HAD A SECOND SAMPLE COLLECTED; THE TSH (3RD IS) RESULT WAS 17.10 IU/ML. ON (B)(6) 2017, THE PATIENT HAD A THIRD SAMPLE COLLECTED; THE ACCESS TSH (3RD IS) RESULT WAS 12.02 I

  Patient problems: No Code Available

  MAUDE report 6883069 ↗