Access HYPERsensitive hTSH 33820Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15099590575311), received between Mar 21, 2017 and Feb 15, 2019 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2019High Test Results; High Test Results

  ON (B)(6) 2019, THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE FTSH2 (ACCESS TSH (3RD IS)) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). THE INITIAL ELEVATED ACCESS TSH RESULT OF 41.56 UIU/ML WAS RELEASED FROM THE LABORATORY. THE CUSTOMER'S NORMAL REFERENCE RANGE WAS NOT PROVIDED. THE PATIENT WAS SUBSEQUENTLY ADMINISTERED THYROID MEDICATION. THERE WAS NO ADDITIONAL CHANGE TO OR IMPACT TO PATIENT CARE REPORTED IN ASSOCIATION WITH THIS EVENT. CALIBRATION AND QUALITY CONTROL WERE ALL RECOVERING WITHIN EXPECTED PARAMETERS AT THE TIME OF THE INCIDENT. DETAILS REGARDING SAMPLE TYPE, SAMPLE HANDLING AND CENTRIFUGATION WERE NOT PROVIDED. NO SAMPLE INTEGRITY ISSUES WERE NOTED.

  Patient problems: No Code Available

  MAUDE report 8345500 ↗
• InjuryJun 19, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING A NON-REPRODUCIBLE THYROID STIMULATING HORMONE (ACCESS TSH) RESULT INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) FOR ONE (1) PATIENT. THE PATIENT'S SAMPLE WAS REPEATED ON AN ALTERNATE ANALYZER, METHODOLOGY UNKNOWN, AND A LOWER RESULT WAS OBTAINED. THE INITIAL, ELEVATED ACCESS TSH RESULT WAS RELEASED FROM THE LABORATORY. THERE WAS CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN ASSOCIATION WITH THE NON-REPRODUCIBLE ACCESS TSH RESULT AS UNKNOWN MEDICATION WAS EITHER STARTED OR STOPPED AND UNKNOWN PROCEDURES WERE PERFORMED. QUALITY CONTROL (QC) AND CALIBRATION WERE PERFORMING WITHIN THE ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. NO INFORMATION REGARDING SAMPLE COLLECTION OR PROCESSING WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Code Available

  MAUDE report 6651115 ↗
• InjuryMay 5, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING REPRODUCIBLY ELEVATED TSH (THYROID STIMULATING HORMONE) RESULTS FOR ONE PATIENT ON THE LABORATORY'S UNICEL DXI800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE RESULTS WERE DETERMINED TO BE DISCORDANT WITH REPRODUCIBLY LOWER TSH RESULTS OBTAINED FOR THE SAME PATIENT BY ALTERNATE METHODS (ROCHE, SIEMENS AND ABBOT). CUSTOMER-PROVIDED DATA INDICATE THAT ELEVATED ACCESS TSH RESUTLS WERE ALSO GENERATED FOR THIS PATIENT ON AN ALTERNATE UNICEL DXI800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) AND ACCESS2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT THE PATIENT HAD BEEN INAPPROPRIATELY DIAGNOSED WITH AND TREATED FOR HYPOTHYROIDISM DUE TO THE ELEVATED ERRONEOUS TSH RESULTS. THE CUSTOMER INDICATED THAT THE PATIENT HAD BEEN INAPPROPRIATELY PRESCRIBED THE MAXIMUM DOSAGE OF LEVOTHYROXINE. THE CUSTOMER DID NOT INDICATE SAMPLE TYPE BUT DID RELATE THAT SAMPLES WERE CENTRIFUGED FOR 10 MINUTES AT 3500 RPM (ROTATIONS PER MINUTE). THE CUSTOMER REPORTED THAT TSH QC (QUALITY CONTROL) RESULTS GENERATED ON THE SYSTEM HAD BEEN ACCEPTABLE.

  Patient problems: No Code Available

  MAUDE report 6547617 ↗
• InjuryMar 21, 2017False Positive Result; False Positive Result

  THE CUSTOMER CONTACTED BECKMAN COULTER ON (B)(6) 2017 TO REPORT GENERATING A NON-REPRODUCIBLE ELEVATED THYROID STIMULATING HORMONE (ACCESS HTSH) RESULTS FOR ONE (1) PATIENT ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4). THE PATIENT'S ELEVATED ACCESS HTSH SAMPLE WAS REPEATED ON AN ALTERNATE SYSTEM (METHODOLOGY UNKNOWN) AND THE RESULT WAS REPORTED TO BE NORMAL. IT WAS NOTED THAT ADDITIONAL THYROID ASSAYS (ACCESS FREET3, ACCESS FREET4, ACCESS TOTAL T3 AND ACCESS TOTAL T4) WERE PERFORMED, FOR THE SAME PATIENT AND ALL RESULTS, RECOVERED WITH IN EACH ASSAY'S NORMAL REFERENCE RANGE. THERE WAS CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT, WHICH OCCURRED IN ASSOCIATION WITH THE NON-REPRODUCIBLE, ELEVATED ACCESS HTSH RESULT; AS THE PREGNANT PATIENT WAS ADMINISTERED MEDICATION. THE CUSTOMER DID NOT PROVIDE SAMPLE COLLECTION INFORMATION. QUALITY CONTROL (QC) AND SYSTEM CHECK PARAMETERS WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT.

  Patient problems: No Code Available

  MAUDE report 6420832 ↗