Access Thyroglobulin 33860Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15099590227173), received between Dec 31, 2018 and Jul 27, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “High Test Results” (4 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 10, 2025Open, Classified

   Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.

   Z-2322-2025 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryJul 27, 2026High Test Results

  On 26JUN2026, the customer reported false positive Access Thyroglobulin (Part Number: 33860; Lot Number: 539320) were generated on their DxI 800 Access instrument (Part Number: A71456; Serial Number: (b)(6)). There was a change to patient management reported for two patients. One patient had false positive results reported outside the laboratory and underwent imaging, including ultrasound and uptake scans. There was no report of further harm to the patient as a result of the change in treatment. Note: As two patients were involved, two MedWatch reports will be submitted, one for each patient.The customer elaborated that they had noticed increased positive results and discrepancies with LC-MS, mass spec results. The negativity rate had dropped significantly. The customer stated the questioned results started on (b)(6) 2026 and after retrospective review, the doctor confirmed the two patients which had undergone imaging that they would not have needed otherwise. No other assay or hardware issues were reported in conjunction with this event. Quality Controls were passing within the laboratories established means Calibration passed on (b)(6) 2026, (b)(6) 2026 and (b)(6) 2026 using reag

  Patient problems: Insufficient Information

  MAUDE report 50012406 ↗
• InjuryJul 27, 2026High Test Results

  On (b)(6) 2026, the customer reported false positive Access Thyroglobulin (Part Number: 33860; Lot Number: 539320) were generated on their DxI 800 Access instrument (Part Number: A71456; Serial Number: (b)(6).There was a change to patient management reported for two patients. One patient had false positive results reported outside the laboratory and underwent imaging, including ultrasound and uptake scans. There was no report of further harm to the patient as a result of the change in treatment.Note: As two patients were involved, two MedWatch reports will be submitted, one for each patient.The customer elaborated that they had noticed increased positive results and discrepancies with LC-MS, mass spec results. The negativity rate had dropped significantly.The customer stated the questioned results started on (b)(6) 2026 and after retrospective review, the doctor confirmed the two patients which had undergone imaging that they would not have needed otherwise.No other assay or hardware issues were reported in conjunction with this event.Quality Controls were passing within the laboratories established means Calibration passed on (b)(6) 2026 using reagent lot 539320 and calibrator lot

  Patient problems: Insufficient Information

  MAUDE report 50012372 ↗
• InjuryAug 12, 2025High Test Results; High Test Results

  ON (B)(6) 2025, THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TG (ACCESS THYROGLOBULIN, PART NUMBER: 33860, LOT NUMBER: 439163) PATIENT RESULTS, GENERATED ON THEIR DXI 800 ANALYZERS (PART: A71456, SERIAL NUMBERS: (B)(6). THE CUSTOMER VERBALLY STATED THEY HAVE SEEN THIS ISSUE ONGOING SINCE ON (B)(6) 2025, HOWEVER, ONE PATIENT ON (B)(6) 2025 HAD THE FOLLOWING RESULTS GENERATED AND UNDERWENT A CHANGE TO TREATMENT: THE INITIAL RESULT FOR THIS PATIENT WAS 4.3 NG/ML ON (B)(6) 2025 ON DXI 800 SERIAL NUMBER (SN): (B)(6). THE PATIENT SAMPLE WAS SENT TO (B)(6) FOR TESTING ON THEIR DXI 800 WITH A RESULT OF < 0.1 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED ON BOTH THE INITIAL CUSTOMER INSTRUMENT, SN: (B)(6), AND THE CUSTOMER¿S OTHER DXI 800, SN: (B)(6) ON (B)(6) 2025. 609235 REPEAT RESULTS ¿ 4.6 AND 4.3 NG/ML. 609234 REPEAT RESULTS ¿ 4.2 AND 4.2 NG/ML. THE CUSTOMER REPORTED THIS PATIENT HAD ADDITIONAL SCANS PERFORMED WHICH WERE NEGATIVE FOR CANCER. A CT (COMPUTED TOMOGRAPHY) SCAN WITH 100 CC'S OF OMNIPAQUE 350 CONTRAST DYE AND A PET SCAN WITH 13.94 MCI OF F-18 FDG WERE PERFORMED. NO FURTHER INFORMATION REGARDING THE PATIENT TREATMENT WAS PROVIDED. THE PATIENT RESULTS WERE BELOW THE AMR (ASSAY M

  Patient problems: Insufficient Information

  MAUDE report 22787575 ↗
• InjuryDec 31, 2018High Test Results; High Test Results

  ON (B)(6) 2018 THE CUSTOMER REPORTED THAT REPRODUCIBLE ELEVATED THYROGLOBULIN (ACCESS THYROGLOBULIN) RESULTS HAD BEEN GENERATED ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE ELEVATED ACCESS THYROGLOBULIN RESULTS WERE RELEASED FROM THE LABORATORY. THE PATIENT'S SAMPLES WERE ANALYZED UTILIZING OTHER METHODOLOGIES AND RECOVERED WITH NEGATIVE RESULTS. ACTUAL RESULTS WERE NOT PROVIDED. THERE WAS A REPORT OF CHANGE TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE PATIENT UNDERWENT MRI (MAGNETIC RESONANCE IMAGING). THERE WAS NO REPORT OF FURTHER INJURY OR CHANGE TO PATIENT MANAGEMENT REPORTED IN THIS EVENT. CALIBRATION, QUALITY CONTROL AND SYSTEM CHECK WERE ALL PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE INCIDENT. INFORMATION REGARDING PATIENT SAMPLE COLLECTION AND PROCESSING WAS NOT PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8206504 ↗