Access Hybritech PSA 37200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H628372001), received between Nov 16, 2015 and Dec 8, 2015 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2015Low Test Results

  ON (B)(6) 2015, THE CUSTOMER REPORTED ONE (1) NON-REPRODUCIBLY FALSE LOW PROSTATE-SPECIFIC ANTIGEN (ACCESS HYBRITECH PSA) RESULT WHICH WAS OBTAINED ON THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE (1) PATIENT. THE INITIAL ACCESS HYBRITECH PSA RESULT OF 82.069 NG/ML WAS REPORTED OUTSIDE OF THE LABORATORY. THE LAB TECHNICIAN QUESTIONED THE RESULT AND THE SAME SAMPLE WAS REPEATED EIGHT (8) TIMES ON THE SAME UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE REPEATED RESULTS RECOVERED REPRODUCIBLY HIGH WITH RESULTS OF 128.2 NG/ML, 132.691 NG/ML, 143.183 NG/ML, 142.8 NG/ML, 137.595 NG/ML, 139.784 NG/ML, 142.48 NG/ML AND 135.734 NG/ML OBTAINED. THERE WERE NO REPORTS OF PATIENT INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. CALIBRATION PRIOR TO THIS EVENT WAS PASSING ASSAY SPECIFICATIONS. ONE LEVEL OF QUALITY CONTROL (QC) WAS RUNNING OUT OF THE CUSTOMER'S ESTABLISHED RANGE ON THE DATE OF EVENT. A SYSTEM CHECK PERFORMED AFTER THIS EVENT WAS PASSING WITHIN INSTRUMENT SPECIFICATIONS. THERE WERE NO ERRORS POSTED IN THE EVENT LOG. TWO (2) PRECISION STUDIES WERE PERFORMED USING LEVEL 3 QC. THE PRECISION STUDIES MET ASSAY AND SYSTEM SPECIF

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5274517 ↗
• MalfunctionNov 16, 2015Low Test Results

  THE CUSTOMER REPORTED REPRODUCIBLY ERRONEOUS PROSTATE-SPECIFIC ANTIGEN (ACCESS HYBRITECH PSA) RESULTS OBTAINED ON TWO (2) SAMPLES WHICH WERE OBTAINED ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE (1) PATIENT. THE ACCESS HYBRITECH PSA TESTS WERE PERFORMED AS PART OF A PROSTATE HEALTH INDEX (PHI) TEST. TESTING WAS PERFORMED ON THE FIRST SAMPLE ON (B)(6), 2015 WITH AN INITIAL ACCESS HYBRITECH PSA RESULT OF 0.47 NG/ML. THE SAME SAMPLE WAS REPEATED AND A REPRODUCIBLE RESULT OF 0.48 NG/ML WAS OBTAINED. A SECOND SAMPLE WAS OBTAINED FROM THE SAME PATIENT AND WAS TESTED ON (B)(6), 2015 WITH AN ACCESS HYBRITECH PSA RESULT OF 0.45 NG/ML. MDR 2122870-2015-00754 WAS CREATED TO ADDRESS THE RESULT OBTAINED ON THE (B)(6), 2015. THE PATIENT'S SAMPLES WERE ALSO TESTED USING THE ARCHITECT AND ROCHE ANALYZER (ALTERNATE METHODOLOGIES) AND BOTH RECOVERED WITH A HIGHER PSA RESULT. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO REPORTS OF PATIENT INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. SAMPLE HANDLING AND PROCESSING INFORMATION WERE NOT PROVIDED FOR REVIEW. NO SAMPLE INTEGRITY ISSUES WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5226544 ↗
• MalfunctionNov 16, 2015Low Test Results

  THE CUSTOMER REPORTED REPRODUCIBLY ERRONEOUS PROSTATE-SPECIFIC ANTIGEN (ACCESS HYBRITECH PSA) RESULTS OBTAINED ON TWO (2) SAMPLES WHICH WERE OBTAINED ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE (1) PATIENT. THE ACCESS HYBRITECH PSA TESTS WERE PERFORMED AS PART OF A PROSTATE HEALTH INDEX (PHI) TEST. TESTING WAS PERFORMED ON THE FIRST SAMPLE ON (B)(6) 2015 WITH AN INITIAL ACCESS HYBRITECH PSA RESULT OF 0.47 NG/ML. THE SAME SAMPLE WAS REPEATED AND A REPRODUCIBLE RESULT OF 0.48 NG/ML WAS OBTAINED. A SECOND SAMPLE WAS OBTAINED FROM THE SAME PATIENT AND WAS TESTED ON (B)(6) 2015 WITH AN ACCESS HYBRITECH PSA RESULT OF 0.45 NG/ML. MDR 2122870-2015-00755 WAS CREATED TO ADDRESS THE RESULT OBTAINED ON THE (B)(6) 2015. THE PATIENT'S SAMPLES WERE ALSO TESTED USING THE ARCHITECT AND ROCHE ANALYZER (ALTERNATE METHODOLOGIES) AND BOTH RECOVERED WITH A HIGHER PSA RESULT. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO REPORTS OF PATIENT INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. SAMPLE HANDLING AND PROCESSING INFORMATION WERE NOT PROVIDED FOR REVIEW. NO SAMPLE INTEGRITY ISSUES WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5226485 ↗