Procleix Ultrio Elite Assay Discriminatory Probe KitRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00859882007603), received between Apr 20, 2022 and Oct 7, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “False Negative Result” (7 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 18, 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.

• InjuryOct 7, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022, GRIFOLS CUSTOMER GIFT OF HOPE (UNITED STATES OF AMERICA) REPORTED A CASE OF HBV TRANSFUSION TRANSMISSION INFECTION (TTI) FOR THE RECIPIENT OF A HEART FROM A BEATING HEART ORGAN DONOR. THE DONOR OF THE HEART WAS TESTED WITH SEROLOGY AND THE PROCLEIX ULTRIO ELITE SCREENING ASSAYS AND THEY WERE BOTH NONREACTIVE. THERE WAS ALSO A HBV TTI EVENT FOR THE KIDNEY RECIPIENT FROM THE SAME DONOR THAT IS DOCUMENTED UNDER A SEPARATE REPORT (2032600-2022-00007). SAMPLES FROM THE DONOR WERE TESTED ON (B)(6) 2022 AND GAVE THE FOLLOWING RESULTS: ABBOTT ALINITY ANTI-HBC: NONREACTIVE, ABBOTT ALINITY HBSAG: NONREACTIVE, ULTRIO ELITE SCREENING: NONREACTIVE. ULTRIO ELITE ML 703564 WAS USED FOR TESTING. THE TTI WAS DISCOVERED WHEN THE PATIENT WHO RECEIVED THEIR HEART TRANSPLANT COMPLETED THEIR POST-OPERATIVE FOLLOW-UP TESTING (EXACT DATE UNKNOWN, APPROXIMATELY 4 TO 6 WEEKS POST-OP) AND THEY TESTED HBV POSITIVE. ADDITIONAL DETAILS OF THE TESTING WERE REQUESTED BUT THE ONLY INFORMATION THE CUSTOMER PROVIDED WAS THAT THE TRANSPLANT TEAM USED AN HBV DNA QUANT TEST. THE CUSTOMER DECLINED TO PROVIDE ANY INFORMATION FROM THE DONOR QUESTIONNAIRE, CITING CONFIDENTIALITY. THE SAMPLE TUBES USED FOR P

  Patient problems: Hepatitis

  MAUDE report 15558760 ↗
• InjuryOct 7, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022, GRIFOLS CUSTOMER GIFT OF HOPE (UNITED STATES OF AMERICA) REPORTED A CASE OF HBV TRANSFUSION TRANSMISSION INFECTION (TTI) FOR THE RECIPIENT OF A KIDNEY FROM A BEATING HEART ORGAN DONOR. THE DONOR OF THE KIDNEY WAS TESTED WITH SEROLOGY AND THE PROCLEIX ULTRIO ELITE SCREENING ASSAYS AND THEY WERE BOTH NONREACTIVE. THERE WAS ALSO A HBV TTI EVENT FOR THE HEART RECIPIENT THAT IS DOCUMENTED UNDER A SEPARATE REPORT (2032600-2022-00008). SAMPLES FROM THE DONOR WERE TESTED ON (B)(6) 2022 AND GAVE THE FOLLOWING RESULTS: ABBOTT ALINITY ANTI-HBC: NONREACTIVE, ABBOTT ALINITY HBSAG: NONREACTIVE, ULTRIO ELITE SCREENING: NONREACTIVE. ULTRIO ELITE ML 703564 WAS USED FOR TESTING. THE TTI WAS DISCOVERED WHEN THE PATIENT WHO RECEIVED THE KIDNEY TRANSPLANT COMPLETED THEIR POST-OPERATIVE FOLLOW-UP TESTING (EXACT DATE UNKNOWN, APPROXIMATELY 4 TO 6 WEEKS POST-OP) AND THEY WERE HBV POSITIVE. ADDITIONAL DETAILS OF THE TESTING WERE REQUESTED BUT THE ONLY INFORMATION THE CUSTOMER PROVIDED WAS THAT THE TRANSPLANT TEAM USED AN HBV PCR TEST. THE CUSTOMER DECLINED TO PROVIDE ANY INFORMATION FROM THE DONOR QUESTIONNAIRE, CITING CONFIDENTIALITY. THE SAMPLE TUBES USED FOR PROCLEIX (K2EDTA) AND SEROLOG

  Patient problems: Hepatitis

  MAUDE report 15558448 ↗
• InjuryOct 6, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022, GRIFOLS CUSTOMER GIFT OF HOPE (UNITED STATES OF AMERICA) REPORTED GETTING DISCORDANT RESULTS BETWEEN SEROLOGY AND THE PROCLEIX ULTRIO ELITE ASSAY FOR A BEATING HEART ORGAN DONOR. HIV RESULTS FOR BOTH SEROLOGY (ABBOTT ALINITY ANTI-HCV) AND PROCLEIX ULTRIO ELITE SCREENING AND DHIV ASSAY RESULTS WERE NONREACTIVE. HBV AND HCV RESULTS WERE DISCORDANT, GIVING THE FOLLOWING RESULTS: ABBOTT ALINITY ANTI-HBC: REACTIVE, ABBOTT ALINITY HBSAG: NONREACTIVE, ABBOTT ALINITY ANTI-HCV: REACTIVE, PROCLEIX ULTRIO ELITE SCREENING: NONREACTIVE IN DUPLICATE, ULTRIO ELITE DHBV: REACTIVE IN DUPLICATE, ULTRIO ELITE DHCV: NONREACTIVE IN DUPLICATE. THE SAME PROCLEIX PANTHER INSTRUMENT AND ULTRIO ELITE (ML 704542) WERE USED FOR ALL PROCLEIX ULTRIO ELITE TESTING. THE CUSTOMER DECLINED TO PROVIDE ANY INFORMATION FROM THE DONOR QUESTIONNAIRE, CITING CONFIDENTIALITY. THE ORGANS FROM THIS DONOR WERE FLAGGED AS KNOWN HCV/HBV INFECTED STATUS AND WERE USED FOR TRANSPLANT IN ACCORDANCE WITH THE TESTING SITES OPERATING PROCEDURES. GRIFOLS IS INVESTIGATING THE DISCORDANT HBV RESULTS BETWEEN ULTRIO ELITE SCREENING (NONREACTIVE) AND SEROLOGY (REACTIVE) AND ULTRIO ELITE DHBV (REACTIVE), AS WELL AS THE DISCO

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15557663 ↗
• InjuryApr 20, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022, (B)(6) HOSPITAL ((B)(6)) REPORTED FOUR (B)(6), (B)(6) SAMPLES THAT WERE NONREACTIVE IN THE PROCLEIX ULTRIO ELITE DISCRIMINATORY (B)(6) MASTER LOT (ML) 703890. THE FOUR SAMPLES WERE ALSO TESTED IN (B)(6), AND EACH HAD HCV TITER GREATER THAN EQUAL TO 35 IU/ML (ABOVE THE 2.4 IU/ML LOD OF THE UE (B)(6)). NO REMAINING SAMPLE VOLUME IS AVAILABLE FOR INVESTIGATION AND THERE IS NO OPTION FOR A NEW BLOOD DRAW. NO CUSTOMER INFORMATION IS AVAILABLE AT THIS TIME. SAMPLES AND DONORS WERE BLOCKED FROM USE. THOUGH REPORTED TO GRIFOLS ON (B)(6 )2022, THE COMPLAINT WORK ORDER WAS NOT CREATED UNTIL (B)(6) 2022. DURING QA REVIEW OF THE WORK ORDER, THE COMPLAINT WAS RECLASSIFIED AS POTENTIAL HEALTH AND SAFETY COMPLAINTS" AND LATER THE PRODUCT QUALITY COMMITTEE DETERMINED THIS EVENT WAS MDR REPORTABLE. INVESTIGATION INTO THIS DELAY IS ONGOING. AN INVESTIGATION IS ONGOING TO DETERMINE THE ROOT CAUSE FOR THESE NONREACTIVE RESULTS IN THE ULTRIO ELITE (B)(6) ASSAY. THE CUSTOMER IS USING THE DISCRIMINATORY ASSAYS TO CONFIRM POSITIVE SEROLOGY RESULTS, RATHER THAN INITIALLY SCREENING WITH THE ULTRIO ELITE MULTIPLEX ASSAY AND TESTING SAMPLES WITH REACTIVE RESULTS IN THE DISCRIMINATORY ASSAYS PE

  Patient problems: Insufficient Information

  MAUDE report 14163728 ↗
• InjuryApr 20, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022, GRIFOLS DISTRIBUTOR (B)(6) REPORTED FOUR (B)(6) SAMPLES THAT WERE (B)(6) IN THE PROCLEIX ULTRIO ELITE DISCRIMINATORY HCV ASSAY (UE DHCV) MASTER LOT (ML) 703890. THE FOUR SAMPLES WERE ALSO TESTED IN (B)(6) QUANT, AND EACH HAD (B)(6) TITER GREATER THAN EQUAL TO (B)(6). NO REMAINING SAMPLE VOLUME IS AVAILABLE FOR INVESTIGATION AND THERE IS NO OPTION FOR A NEW BLOOD DRAW. NO CUSTOMER INFORMATION IS AVAILABLE AT THIS TIME. SAMPLES AND DONORS WERE BLOCKED FROM USE. THOUGH REPORTED TO GRIFOLS ON (B)(6) 2022, THE COMPLAINT WORK ORDER WAS NOT CREATED UNTIL 05APR2022. DURING QA REVIEW OF THE WORK ORDER, THE COMPLAINT WAS RECLASSIFIED AS POTENTIAL HEALTH AND SAFETY COMPLAINTS" AND LATER THE PRODUCT QUALITY COMMITTEE DETERMINED THIS EVENT WAS MDR REPORTABLE. INVESTIGATION INTO THIS DELAY IS ONGOING. AN INVESTIGATION IS ONGOING TO DETERMINE THE ROOT CAUSE FOR THESE (B)(6) RESULTS IN THE ULTRIO ELITE DHCV ASSAY. THE CUSTOMER IS USING THE DISCRIMINATORY ASSAYS TO CONFIRM (B)(6) SEROLOGY RESULTS, RATHER THAN INITIALLY SCREENING WITH THE ULTRIO ELITE MULTIPLEX ASSAY AND TESTING SAMPLES WITH (B)(6) RESULTS IN THE DISCRIMINATORY ASSAYS PER THE PACKAGE INSERT. A REVIEW OF THE QUALITY C

  Patient problems: Insufficient Information

  MAUDE report 14163687 ↗
• InjuryApr 20, 2022False Negative Result; False Negative Result

  ON 12FEB2022, (B)(4) DISTRIBUTOR (B)(6) REPORTED FOUR HCV SEROLOGY POSITIVE SAMPLES THAT WERE NONREACTIVE IN THE PROCLEIX ULTRIO ELITE DISCRIMINATORY HCV ASSAY (UE DHCV) MASTER LOT (ML) 703890. THE FOUR SAMPLES WERE ALSO TESTED IN HCV QUANT, AND EACH HAD HCV TITER GREATER THAN EQUAL TO 35 IU/ML (ABOVE THE 2.4 IU/ML LOD OF THE UE DHCV ASSAY). NO REMAINING SAMPLE VOLUME IS AVAILABLE FOR INVESTIGATION AND THERE IS NO OPTION FOR A NEW BLOOD DRAW. NO CUSTOMER INFORMATION IS AVAILABLE AT THIS TIME. SAMPLES AND DONORS WERE BLOCKED FROM USE. THOUGH REPORTED TO GRIFOLS ON 12FEB2022, THE COMPLAINT WORK ORDER WAS NOT CREATED UNTIL 05APR2022. DURING QA REVIEW OF THE WORK ORDER, THE COMPLAINT WAS RECLASSIFIED AS [?]POTENTIAL HEALTH AND SAFETY COMPLAINTS" AND LATER THE PRODUCT QUALITY COMMITTEE DETERMINED THIS EVENT WAS MDR REPORTABLE. INVESTIGATION INTO THIS DELAY IS ONGOING. AN INVESTIGATION IS ONGOING TO DETERMINE THE ROOT CAUSE FOR THESE NONREACTIVE RESULTS IN THE ULTRIO ELITE DHCV ASSAY. THE CUSTOMER IS USING THE DISCRIMINATORY ASSAYS TO CONFIRM POSITIVE SEROLOGY RESULTS, RATHER THAN INITIALLY SCREENING WITH THE ULTRIO ELITE MULTIPLEX ASSAY AND TESTING SAMPLES WITH REACTIVE RESULTS IN THE D

  Patient problems: Hepatitis

  MAUDE report 14163619 ↗
• InjuryApr 20, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022, GRIFOLS DISTRIBUTOR (B)(6) HOSPITAL ((B)(6)) REPORTED FOUR HCV SEROLOGY POSITIVE SAMPLES THAT WERE NONREACTIVE IN THE PROCLEIX ULTRIO ELITE DISCRIMINATORY HCV ASSAY (UE DHCV) MASTER LOT (ML) 703890. THE FOUR SAMPLES WERE ALSO TESTED IN HCV QUANT, AND EACH HAD HCV TITER GREATER THAN EQUAL TO 35 IU/ML (ABOVE THE 2.4 IU/ML LOD OF THE UE DHCV ASSAY). NO REMAINING SAMPLE VOLUME IS AVAILABLE FOR INVESTIGATION AND THERE IS NO OPTION FOR A NEW BLOOD DRAW. NO CUSTOMER INFORMATION IS AVAILABLE AT THIS TIME. SAMPLES AND DONORS WERE BLOCKED FROM USE. THOUGH REPORTED TO GRIFOLS ON (B)(6) 2022, THE COMPLAINT WORK ORDER WAS NOT CREATED UNTIL (B)(6) 2022. DURING QA REVIEW OF THE WORK ORDER, THE COMPLAINT WAS RECLASSIFIED AS [?]POTENTIAL HEALTH AND SAFETY COMPLAINTS" AND LATER THE PRODUCT QUALITY COMMITTEE DETERMINED THIS EVENT WAS MDR REPORTABLE. INVESTIGATION INTO THIS DELAY IS ONGOING. AN INVESTIGATION IS ONGOING TO DETERMINE THE ROOT CAUSE FOR THESE NONREACTIVE RESULTS IN THE ULTRIO ELITE DHCV ASSAY. THE CUSTOMER IS USING THE DISCRIMINATORY ASSAYS TO CONFIRM POSITIVE SEROLOGY RESULTS, RATHER THAN INITIALLY SCREENING WITH THE ULTRIO ELITE MULTIPLEX ASSAY AND TESTING SAMPLES WITH

  Patient problems: Hepatitis

  MAUDE report 14163600 ↗