Access Intact PTH A16972Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15099590201937), received between Feb 6, 2017 and Mar 31, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 reports).

2 FDA recall records name this device's identifier, 2 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. Nov 26, 2024Open, Classified

   Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.

   Z-0803-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Nov 8, 2024Open, Classified

   The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition.

   Z-0673-2025 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2026. THE CUSTOMER REPORTED A DELAY TO PATIENT TREATMENT DUE TO QUALITY CONTROL (QC) FAILURE FOR THE ACCESS PTHIO ASSAY (PARATHYROID HORMONE REAGENT PART: A16972, LOT NUMBER: 539221) ON THEIR DXI 9000 IMMUNOASSAY ANALYZER (PART NUMBER: C11137, SERIAL NUMBER: (B)(6) FOR ONE PATIENT. THE CUSTOMER STATED THAT A SURGICAL PROCEDURE WAS DELAYED APPROXIMATELY 60 MINUTES, WITH NO FURTHER IMPACT TO THE PATIENT. NO DEATH OR INJURY OCCURRED. THE QC DATA PROVIDED DEMONSTRATES THAT LEVEL 1 AND LEVEL 2 QC WERE WITHIN LABORATORY¿S ESTABLISHED RANGES SINCE ON (B)(6) 2026, WITH VALUES BEING WITHIN 1 STANDARD DEVIATION (SD). LEVEL 3 QC WAS ON THE HIGHER SIDE OF THE CUSTOMER¿S RANGE ON (B)(6) 2026 WITH VALUES CLOSE TO 2SD, BUT STILL WITHIN RANGES. NO HARDWARE OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PROVIDED FOR REVIEW. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 24743945 ↗
• InjuryFeb 24, 2025High Test Results; High Test Results

  ON 31JAN2025, THE CUSTOMER REPORTED QUESTIONED, ELEVATED PATIENT RESULTS WITH THE ACCESS PTH (ACCESS PARATHYROID, PART A16972, LOT NUMBER 439206) ON THE LABORATORY'S DXI 600 ACCESS IMMUNOASSAY W/SPOT B (PART NUMBER A71460, SERIAL NUMBER (B)(6)). ACCESS PTH RESULT: 116 PG/ML (HIGH, >88 PG/ML) ON (B)(6) 2024. THE PATIENT WAS SCHEDULED FOR PARATHYROIDECTOMY AND PERFORMED COMPUTERIZED TOMOGRAPHY (CT)-SCAN, ULTRASOUND AND NUCLEAR MEDICINE IMAGING (WITH DYE) BASED UPON THIS ELEVATED PTH RESULT. THE CUSTOMER REPORTED THE ELEVATED RESULT WAS DISCORDANT WITH THE NORMAL RESULT OBTAINED FROM AN ALTERNATE HOSPITAL (METHOD UNKNOWN) AND THE PATIENT CLINICAL FILE (NORMAL CT-SCAN/ULTRASOUND/NUCLEAR MEDICINE IMAGING RESULTS). ALTERNATE LABORATORY PTH RESULT (METHOD UNKNOWN): 42 PG/ML (NORMAL) IN LATE (B)(6) 2024. THE PARATHYROIDECTOMY WAS CANCELLED BASED UPON THIS NORMAL PTH RESULT AND NORMAL CT-SCAN/ULTRASOUND/NUCLEAR MEDICINE IMAGING RESULTS. NO ISSUES WITH SAMPLES INTEGRITY WERE REPORTED BY THE CUSTOMER. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK PASSED ON 23MAY2024. PTHIO (INTEROPERATIVE MODE) CALIBRATION PASSED ON 09JUN2024/18JUN2024/07J

  Patient problems: Insufficient Information

  MAUDE report 21443723 ↗
• MalfunctionNov 8, 2024Low Test Results; Low Test Results

  ON (B)(6) 2024, THE CUSTOMER REPORTED DISCREPANT PTH (ACCESS INTACT PTH, PART NUMBER: A16972 AND LOT NUMBER: 472012) RESULTS WERE GENERATED BETWEEN THE CUSTOMER'S DXI 9000 SERIAL NUMBERS S/N: (B)(6). THE CUSTOMER REPORTED FOURTEEN (14) PATIENT SAMPLES WITH A SIGNIFICATIVE DIFFERENCE UPON REPEAT BETWEEN TWO DXI 9000 INSTRUMENTS S/N: (B)(6) (REFER TO RELEVANT TESTS SECTION BELOW). HOWEVER, ALL RESULTS WERE ELEVATED AND ABOVE THE PTH EXPECTED VALUES: 12-88 NG/L. PER CUSTOMER VERBAL REPORT, THE ISSUE WAS FIRST NOTED ON (B)(6) 2024. THE DATA PROVIDED SHOWS PTH PATIENT RESULTS OBTAINED ON THE CUSTOMER¿S DXI 9000 ANALYZER SERIAL NUMBER: (B)(6) (DXI-5) ARE BETWEEN -17% TO -57% LOWER THAN THE RESULTS OBTAINED ON THE OTHER DXI 9000 ANALYZER (DXI-1 - SERIAL NUMBER: (B)(6). THERE WAS NO REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS INCIDENT. NO HARDWARE ISSUES, NO FLAGS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER ASSAY RESULT WAS QUESTIONED. DXI 9000 S/N: (B)(6): CALIBRATION PASSED ON (B)(6) 2024 WITH REAGENT LOT: 472012 AND CALIBRATOR LOT: 489727. FOR MONTH OF JUNE 2024: QUALITY CONTROL (QC) LEVEL 3 WAS ERRATICALLY OUTSIDE HIGH OF THE 2S

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

  MAUDE report 20641291 ↗
• InjuryDec 16, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED ONE NON-REPEATABLE ERRONEOUSLY ELEVATED PTH (ACCESS INTACT PTH) RESULT HAD BEEN GENERATED ON THE CUSTOMER'S UNICEL DXI 800 IMMUNOASSAY SYSTEM (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE PATIENT¿S PTH RESULT OBTAINED ON (B)(6) 2021 WAS HIGH AT 114.9 PG/ML AND DISCORDANT WITH THE PATIENT CLINICAL FILE (EXPECTED VALUES ARE 12-88 PG/ML). THEN THE PATIENT¿S SUPPLEMENTATION IN CALCIUM WAS STOPPED ON (B)(6) 2021 AND THE PATIENT WAS RETESTED TWICE. THE PTH RESULTS WERE AT 56.8 PG/ML ON (B)(6) 2021 AND AT 39.7 PG/ML ON (B)(6) 2021. AS THE LAST RESULT WAS AS EXPECTED, THE TREATMENT WAS RESTARTED ON (B)(6) 2021. THE PATIENT HAD A NORMAL ADJUSTED CALCIUM AND RENAL FUNCTION AND WAS VITAMIN D SUPPLEMENTED. THE PATIENT IS SUFFERING FROM OSTEOPOROSIS, THE ADDITIONAL PATIENT¿S SUPPLEMENTATION IN CALCIUM WAS TEMPORARILY STOPPED BY THE RHEUMATOLOGIST AFTER THE ELEVATED PTH RESULT WAS OBTAINED. THE TREATMENT WAS STOPPED ON (B)(6) 2021 THEN RESTARTED ON (B)(6) 2021. THERE WAS NO FURTHER REPORT OF AN INJURY OR ILLNESS TO THE PATIENT ATTRIBUTABLE TO THE OUTPUT FROM THE DEVICE IN THIS EVENT. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION W

  Patient problems: Insufficient Information

  MAUDE report 13017280 ↗
• MalfunctionApr 12, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED AN ERRONEOUS ELEVATED PTH (ACCESS INTACT PTH, PART NUMBER A16972 AND LOT NUMBER 922137) PATIENT RESULT OF 2172 PG/ML (REFERENCE RANGE OF 12 - 68 PG/ML) WAS GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THERE WAS NO REPORT OF INJURY OR ILLNESS TO THE PATIENTS IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER REPORTED THE SAMPLE WAS ALSO TESTED ON THREE COMPETITORS' PLATFORMS (ROCHE, ABBOTT AND SIEMENS). RESULTS OBTAINED FROM TESTING ON THESE THREE PLATFORMS WERE LOWER AND WERE WITHIN CLINICAL EXPECTATION FOR THE PATIENT. SEE NEXT SECTION FOR TEST RESULTS. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUG

  Patient problems: Insufficient Information

  MAUDE report 11653821 ↗
• MalfunctionJan 4, 2021High Test Results; High Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED OBTAINING ONE NON-REPRODUCIBLE FALSE ELEVATED PARATHYROID HORMONE PTH(ACCESS INTACT PTH, PART NUMBER A16972, LOT NUMBER 971134) PATIENT RESULT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100, SERIAL NUMBER (B)(4)). THE INITIAL RESULT OF 623.65 PG/ML (12:24) WAS QUESTIONED AND REPEATED AT 24.46 PG/ML (14:57). THE SAMPLE WAS REPEATED TWICE AGAIN AND SIMILAR LOWER RESULTS WERE OBTAINED: 25.13 PG/ML AND 22.95 PG/ML (BOTH AT 17:25). THE CUSTOMER NORMAL REFERENCE RANGE IS 12 - 88 PG/ML. SYSTEM CHECK AND CALIBRATION HAVE BEEN PASSING AND QC WAS WITHIN THE LABORATORY¿S ESTABLISHED RANGES. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THIS EVENT. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. SAMPLE TUBE COLLECTION TYPE WAS NOT PROVIDED. SAMPLE PROCESSING INFORMATION SUCH AS CENTRIFUGATION TIME, SPEED AND TEMPERATURE WERE NOT PROVIDED. THERE WAS NO REPORT OF SAMPLE INTEGRITY ISSUES. NO FURTHER SAMPLE INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108557 ↗
• InjuryMar 5, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE ELEVATED INTACT PARATHYROID HORMONE (ACCESS INTACT PTH) RESULTS FOR TWO PATIENTS INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL (B)(4)). THE CUSTOMER REANALYZED THE PATIENTS' SAMPLES ON THE SAME ACCESS 2 IMMUNOASSAY SYSTEM AND AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL (B)(4)) AND OBTAINED LOWER RESULTS. THE INITIAL RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS A CHANGE TO PATIENT CARE ATTRIBUTABLE TO THIS EVENT FOR ONE PATIENT AS A REPEAT BIOPSY WAS ORDERED BY THE PHYSICIAN DUE TO THE ELEVATED ACCESS INTACT PTH RESULT. THERE WAS NO REPORT OF INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THE SECOND PATIENT. THE CUSTOMER COULD NOT IDENTIFY WHICH OF THE TWO PATIENTS HAD A CHANGE IN TREATMENT. QUALITY CONTROL (QC), CALIBRATION AND SYSTEM CHECK WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WERE NO HARDWARE ERRORS OR OTHER ASSAY ISSUES REPORTED IN CONJUNCTION WITH THIS EVENT. THE PATIENT SAMPLES WERE COLLECTED IN ETHYLENEDIAMINETETRAACETIC ACID (EDTA) PLASMA TUBES AND CENTRIFUGED AT 3000 REVOLUTIONS PER MINUTE (RPM) FOR SEVEN MINUTES AT 5-6 DEGREES CELSIUS.

  Patient problems: No Code Available

  MAUDE report 7313134 ↗
• MalfunctionFeb 6, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ONE PATIENT'S SAMPLE RECOVERED WITH REPRODUCIBLY ELEVATED INTACT PARATHYROID HORMONE (ACCESS INTACT PTH) RESULTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). ON (B)(6) 2016 THE INITIAL ACCESS INTACT PTH RESULT RECOVERED AT 3044.7 PG/ML, ABOVE THE ASSAY'S NORMAL REFERENCE RANGE OF 12 - 88 PG/ML. DILUTION TESTING OF THE SAMPLE WAS PERFORMED ON THE SAME UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND RECOVERED NON-LINEARLY, INDICATING A PATIENT SOURCE INTERFERENT. ON (B)(6) 2016, THE SAME PATIENT'S SAMPLE WAS RETESTED AND RECOVERED WITH A RESULT OF 3055.1 PG/ML, ABOVE THE NORMAL REFERENCE RANGE. DILUTION TESTING WAS REPEATED AND RECOVERED WITH LOWER, NON-LINEAR RESULTS. THE INITIAL ACCESS INTACT PTH RESULT WAS RELEASED FROM THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO PATIENT TREATMENT IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER REPORTED THAT QUALITY CONTROL WAS WITHIN SPECIFICATIONS BEFORE AND AFTER THE EVENT. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. INFORMATION ON CALIBRATION AND SYSTEM CHECK WAS NOT SUPPLIED INFORMATION ON THE PATIENT SAMPLE COLLECTION AN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6305911 ↗