Procleix Ultrio Elite Assay 1K Kit Box 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00859882007665), received between Sep 23, 2021 and May 21, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “False Negative Result” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2024False Negative Result; False Negative Result

  ON 26APR2024, GRIFOLS CUSTOMER LIFENET HEALTH (USA) REPORTED ONE SAMPLE THAT WAS INITIALLY NONREACTIVE WITH ULTRIO ELITE (UE) BUT WAS REACTIVE FOR HIV SEROLOGY (ABBOTT ALINITY S HIV AG/AB COMBO). A SECOND COLLECTION FROM THE SAME DONOR WAS TESTED AND WAS UE REACTIVE (S/CO 1.27) BUT NONREACTIVE IN THE UE DISCRIMINATORY ASSAYS. HIV SEROLOGY WAS ALSO POSITIVE IN THE SECOND COLLECTION. UE MASTER LOT (ML) 706318 WAS USED FOR TESTING. THE CUSTOMER DID NOT REQUEST AN INVESTIGATION. IT IS UNKNOWN IF THE DONATION WAS USED, AND NO DONOR HISTORY IS AVAILABLE. NO SAMPLE IS AVAILABLE FOR INVESTIGATION. CUSTOMER DATA: SAMPLE ID H2412801 (DRAW 1): 19APR2024: UE NONREACTIVE (S/CO 0.15) DATE UNKNOWN: HIV AG/AB REACTIVE SAMPLE ID H2413488 (DRAW 2): 25APR2024: UE REACTIVE (S/CO 1.27) 25APR2024: DHIV NONREACTIVE (S/CO 0.48) 25APR2024: DHCV NONREACTIVE (S/CO 0.05) 25APR2024: DHBV NONREACTIVE (S/CO 0.61) DATE UNKNOWN: HIV AG/AB REACTIVE INVESTIGATION A PREVIOUS EVENTS SEARCH WAS CONDUCTED IN SERVICEMAX SEARCHING FOR RELATED HIV SENSITIVITY ISSUES FOR UE ML 706318 IN THE YEAR PRIOR TO THE REPORTED DATE. THERE WERE 2 PREVIOUS COMPLAINTS WITH INVESTIGATIONS FOR POTENTIAL FALSE NEGATIVE UE HIV RESULTS ACROS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19362086 ↗
• InjuryApr 11, 2024False Negative Result; False Negative Result

  ON 05OCT2023, GRIFOLS CUSTOMER, (B)(6) (MEXICO) REPORTED ONE PLASMA SAMPLE TESTED (B)(6) 2023 THAT WAS NONREACTIVE (S/CO 0.10) WITH ULTRIO ELITE (UE) MASTER LOT (ML) 706866 BUT WAS REACTIVE FOR HBSAG AND HBV REACTIVE IN "COBAS 6800". THE SAMPLE WAS ALSO REACTIVE FOR HBSAG ON (B)(6) 2023. THE DONATION WAS NOT USED. THE CUSTOMER DREW A SECOND SAMPLE FROM THE SAME DONOR ON OR AROUND (B)(6) 2023. THIS SAMPLE WAS REACTIVE IN UE (S/CO 14.42), HBV REACTIVE IN "COBAS 6800", AND HBSAG REACTIVE. AN ALIQUOT OF THIS SECOND SAMPLE WAS ALSO TESTED IN A REAL TIME PCR QUANT ASSAY FOR HBV; THE RESULT WAS HBV NOT DETECTED. THIS COMPLAINT WAS ORIGINALLY REGISTERED AS A NON-COMPLAINT 'ROUTINE SERVICE' WORK ORDER ON 06OCT2023 BY THE REGIONAL GRIFOLS DIAGNOSTIC CUSTOMER TECHNICAL SUPPORT TEAM. THE INVESTIGATION WAS COMPLETED BY THE REGIONAL GRIFOLS DIAGNOSTIC CUSTOMER TECHNICAL SUPPORT TEAM UNDER THE NON-COMPLAINT WORK ORDER WITH THE CONCLUSION THAT LOW TITER HBV WAS THE ROOT CAUSE OF THE DISCORDANT RESULTS. A CUSTOMER LETTER WAS PROVIDED ON 07DEC2023. THE MIS-CATEGORIZATION OF THE COMPLAINT WAS IDENTIFIED DURING THE QUARTERLY AUDIT OF ROUTINE SERVICE AND INQUIRY RECORDS COMPLETED BY GRIFOLS DIAGNOSTIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091136 ↗
• InjuryApr 10, 2024False Negative Result; False Negative Result

  ON (B)(6) 2024, (B)(6) (USA) REPORTED THAT THEY HAD ONE TISSUE/ORGAN DONOR SAMPLE (ID: (B)(6) WITH DISCORDANT HBV RESULTS. ALL ULTRIO ELITE (UE) TESTING WAS COMPLETED USING ML 706881. A SUMMARY OF THE TESTING RESULTS ARE AS FOLLOWS: ON (B)(6) 2024 ANTI-HBC: REACTIVE IN TRIPLICATE (S/CO 8.66, 9.07, 8.18). ON (B)(6) 2024 HBSAG: NONREACTIVE (S/CO 0.25). ON (B)(6) 2024 HIV COMBO: NONREACTIVE (S/CO 0.08). ON (B)(6) 2024 ANTI-HCV: NONREACTIVE (S/CO 0.03). ON (B)(6) 2024 UE SCREENING: NONREACTIVE (S/CO 0.23). ON (B)(6) 2024 UE DHBV REACTIVE (S/CO 4.59 ). ON (B)(6) 2024 UE DHIV NONREACTIVE (S/CO 0.10). ON (B)(6) 2024 UE DHCV NONREACTIVE (S/CO 0.00). NO ORGANS OR TISSUE WERE TRANSPLANTED FROM THE DONOR. NO KNOWN HISTORY OF HBV WAS NOTED IN DONOR MEDICAL HISTORY. NO DONOR SAMPLE IS AVAILABLE FOR INVESTIGATIONAL TESTING. THE CUSTOMER PROVIDED THE ULTRIO ELITE SCREENING WORKLIST. THE CALIBRATOR AND IC VALUES LOOK CONSISTENT AND IN THE EXPECTED RANGE FOR EACH TARGET. THERE IS NO INDICATION THAT THERE WAS ANY RUN PERFORMANCE ISSUE THAT CAUSED THE UE SCREENING NON-REACTIVE RESULT FOR THE SAMPLE IN QUESTION AND THERE WERE NO INSTRUMENT ERRORS. SEROLOGY RESULTS WERE REVIEWED AND EVALUATED AGAINST T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085310 ↗
• InjuryAug 17, 2023False Negative Result; False Negative Result

  ON (B)(6) 2023, CUSTOMER (B)(6), (ITALY) REPORTED NON-REACTIVE RESULT ON ULTRIO ELITE SCREENING ASSAYS AND INTERMITTENT REACTIVITY UPON RETESTS. SAMPLE COLLECTED ON (B)(6) 2023 FROM (B)(6) (TEST TUBE CODE (B)(6)). REPORTED AS COLLECTION OF AUTOLOGOUS STEM CELLS FROM HIV POSITIVE PATIENT; PATIENT UNDER THERAPY. ON (B)(6) 2023, SAMPLE TESTED ON PANTHER 10443 (LOT ULTRIO ELITE 706348 EXPIRING 9/15/24) EDTA PLASMA PROCESSED SAMPLE. NEGATIVE RESULT (S/CO 0.06, RLU 6855). ON (B)(6) 2023, SAMPLE TESTED ON PANTHER 10422 (LOT ULTRIO ELITE 706348 EXPIRING 9/15/24) SAMPLE PROCESSED SERUM. NEGATIVE RESULT (S/CO 0.05, RLU 5612). ON (B)(6) 2023, SAMPLE TESTED ON PANTHER 10421 (LOT ULTRIO ELITE 706348 EXPIRING 9/15/24) SAMPLE PROCESSED SERUM. POSITIVE RESULT (S/CO 8.54 , RLU 855246). DATE UNKOWN, THE REPEAT VALUES FOR THE HIV AG/AB PROFILE ARE AS FOLLOWS: 979 S/CO, 986 S/CO, 990 S/CO, SEROLOGY RESULTS ARE FROM INSTRUMENT ARCHITECT (ABBOTT) (QUALITATIVE TEST) .THE SAMPLE IS LIKELY A LOW TITER HIV SAMPLE DUE TO THE RETROVIRAL TREATMENT, WHICH IS KNOWN TO GIVE INTERMITTENT REACTIVE RESULTS. NO INJURY, DEATH OR MEDICAL INTERVENTION WAS REPORTED FOR THIS INCIDENT BECAUSE THE TRANSFUSION WAS AUTOLOGOUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17567444 ↗
• InjuryApr 6, 2023False Negative Result; False Negative Result

  ON (B)(6) 2023, GRIFOLS CUSTOMER CREATIVE TESTING SOLUTIONS (CTS, FLORIDA) REPORTED ONE ORGAN DONOR SAMPLE (B)(6) THAT WAS NONREACTIVE (S/CO 0.06 ) WITH ULTRIO ELITE (UE) ML 704640 AND REACTIVE (S/CO 24.71) IN THE ULTRIO ELITE HBV DISCRIMINATORY ASSAY (DHBV). IT WAS NONREACTIVE IN THE DISCRIMINATORY HIV AND DISCRIMINATORY HCV ASSAYS (S/COS 0.05 AND 0.00, RESPECTIVELY). THE SITE TESTING PROTOCOL IS TO TEST UE AND DISCRIMINATORY ASSAYS SIMULTANEOUSLY DUE TO TIME CONSTRAINTS. IF UE IS NONREACTIVE, THEIR PROTOCOL IS TO CANCEL DISCRIMINATORY TESTING. IN THIS CASE, THEY DID NOT FOLLOW THEIR PROTOCOL. NO SAMPLE VOLUME IS AVAILABLE FOR INVESTIGATION. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES. (B)(6) 2023: SAMPLE (B)(6) ULTRIO ELITE NONREACTIVE (S/CO 0.06). (B)(6) 2023: SAMPLE (B)(6) DHIV INVALID. (B)(6) 2023: SAMPLE (B)(6) DHCV NONREACTIVE (S/CO 0.00). (B)(6) 2023: SAMPLE (B)(6) DHBV REACTIVE (S/CO 24.71). (B)(6) 2023: SAMPLE (B)(6) DHIV NONREACTIVE (S/CO 0.05). INVESTIGATION. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED, AND CUSTOMER IS UNWILLING/ UNABLE TO PROVIDE RESPONSES: WAS THE ORGAN DONOR HEART BEATING OR NON-HEART BEATING? WHAT WAS THE SAMPLE TYPE (MATRIX)? WAS THE SAM

  Patient problems: Insufficient Information

  MAUDE report 16690950 ↗
• InjuryJan 20, 2023False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  ON 22DEC2022, GRIFOLS CUSTOMER REGIONALNE CENTRUM KRWIODAWSTWA I KRWIOLECZNICTWA W RZESZOWIE (RCKIK W RZESZOWIE, POLAND) REPORTED A DISCREPANT HBV RESULT BETWEEN A PLASMA POOL OF 4 PLASMA DONORS AND ONE OF THE POOL COMPONENTS. THE POOL OF 4 DONORS WAS TESTED ON (B)(6) 2022 AND WAS NONREACTIVE (S/CO 0.18) WITH ULTRIO ELITE MASTER LOT: (ML) 704982. IT WAS NOT TESTED IN THE DISCRIMINATORY ASSAYS. THE FOUR INDIVIDUAL DONOR COMPONENTS OF THE POOL WERE TESTED FOR SEROLOGY ON (B)(6) 2022 AND ONE SAMPLE ((B)(6) WAS HBSAG POSITIVE. IT WAS ALSO HBV REACTIVE WHEN TESTED ON (B)(6) 2022 IN THE ARTUS HBV RG PCR ASSAY. THE SAMPLE WAS THEN TESTED ON (B)(6) 2022 IN ULTRIO ELITE AND WAS REACTIVE (S/CO 11.76). THE INDIVIDUAL DONATION WITH THE HBV REACTIVE NAT AND SEROLOGY RESULTS WAS BLOCKED FROM USE. AN INVESTIGATION IS ONGOING FOR THE DISCREPANT RESULT AND SAMPLE VOLUME IS PENDING RETURN TO GRIFOLS FOR HBV QUANTITATION. A REVIEW OF THE QUALITY CONTROL DATA FOR ULTRIO ELITE ML 704982 WAS PERFORMED. THERE WERE NO RELATED QUALITY EVENTS FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA. FOLLOW-UP INFORMATION FOR THIS REPORT WILL BE PROVIDED WHEN AVAILABLE. FOLLOW-UP: SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16217219 ↗
• InjuryFeb 3, 2022Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, GRIFOLS CUSTOMER PLASMA LAB S.R.O. ((B)(6)) REPORTED DISCREPANT (B)(6) RESULTS BETWEEN PROCLEIX ULTRIO ELITE ASSAY AND ABBOTT ALINITY S ANTI-HCV IN AN INDIVIDUALLY TESTED PLASMA DONATION. THE SAMPLE WAS SIMULTANEOUSLY POSITIVE IN SEROLOGY TESTING ((B)(6)) AND (B)(6) IN THE ULTRIO ELITE ASSAY. THE SAMPLE WAS QUARANTINED TO PREVENT RELEASE FOR FRACTIONATION AND SENT TO THE (B)(6) FOR SUPPLEMENTAL TESTING. ADDITIONAL SEROLOGY TESTING CONFIRMED THE SAMPLE IS POSITIVE FOR (B)(6) ANTIBODIES. BASED ON THE INITIAL SEROLOGY TESTING PERFORMED BY THE CUSTOMER AND SUPPLEMENTAL TESTING PERFORMED BY (B)(6), THE CUSTOMER CONSIDERS THE (B)(6) ULTRIO ELITE RESULT A (B)(6). ADDITIONAL PCR TESTING FROM (B)(6) FOR (B)(6) RNA IS PENDING. TESTING RESULTS ARE SUMMARIZED BELOW. INITIAL TESTING FOR SAMPLE (B)(6): ULTRIO ELITE (B)(6) (S/CO (B)(6)) AND ABBOTT ALINITY S (B)(6) IN 3 REPLICATES (S/COS (B)(6)). SUPPLEMENTAL TESTING: ARCHITECT (B)(6) (S/CO (B)(6)), BIORAD (B)(6) (S/CO (B)(6)), ORTHO (B)(6) (S/CO (B)(6)). PENDING TESTING: (B)(6) RNA PCR (ROCHE HCV TAQMAN). THE ULTRIO ELITE RUN REPORT AND RAW DATA WERE REVIEWED FOR THE RUN PERFORMED. NO ERRORS OR CHEMISTRY ISSUES WERE OBSERVED THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13443059 ↗
• InjurySep 23, 2021Incorrect, Inadequate or Imprecise Result or Readings

  HOLD FOR EM ON (B)(6) 2021, (B)(6) IN SPAIN REPORTED DISCORDANT HBV RESULTS FOR A SAMPLE THAT WAS ORIGINALLY NONREACTIVE WHEN TESTED ON (B)(6) 2021 WITH THE PROCLEIX ULTRIO ELITE ASSAY MASTER LOT 702238. ON (B)(6) 2021, AN ARCHIVE SAMPLE FROM THE SAME DONOR WAS TESTED WITH THE PROCLEIX ULTRIO ELITE ASSAY ML 703038 AND WAS REACTIVE. AS A RESULT OF THE INITIAL NONREACTIVE HBV RESULT, THERE IS A POTENTIAL TRANSFUSION TRANSMITTED INFECTION (TTI) AS A RESULT OF THE INFECTED BLOOD PRODUCT. THE DONOR OF THE SAMPLES HAS BEEN A REGULAR DONOR SINCE 2014. PRIOR TO THE EVENTS DESCRIBED, SAMPLES FROM THIS DONOR HAD ALWAYS TESTED NONREACTIVE/NEGATIVE. A DONATION FROM (B)(6) 2021 WAS REACTIVE (S/CO 14.12) WHEN TESTED ON THE ULTRIO ELITE SCREENING ASSAY ML 703038. THE DONATION WAS THEN TESTED USING THE ULTRIO ELITE DISCRIMINATORY ASSAYS FROM THE SAME ML 703038 RESULTING IN THE FOLLOWING: DHIV NONREACTIVE, DHCV NONREACTIVE, AND DHBV REACTIVE (S/CO 22.27). SEROLOGY TESTING WAS ALSO PERFORMED AND THE RESULTS WERE HBSAG NEGATIVE, ANTI-HBC IGM NEGATIVE, TOTAL ANTIHBC NEGATIVE, ANTIHBE NEGATIVE, AND ANTI-HBS AT 87.52 IU/L. HBV QUANTITATIVE TESTING WAS ALSO PERFORMED AND THE RESULT WAS THAT HBV WAS PRESE

  Patient problems: Insufficient Information

  MAUDE report 12523773 ↗