Procleix Ultrio Elite Assay 5K Kit Box 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00859882007672), received between Nov 11, 2022 and Sep 15, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “False Negative Result” (22 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026False Negative Result

  Customer (b)(6) reported on 10AUG2026 discrepant HBV results with a donor sample that tested nonrepeat reactive on the Ultrio Elite screening assay on (b)(6) 2026 and (b)(6) 2026. A fresh sample was initially taken from the donor on (b)(6) 2026 that tested reactive on Ultrio Elite (3x), HBV discriminatory and Serology (Anti-HBs and Anti-HBc). HbsAg, HBe Ag and Anti- Hbe were negative. A look back at the donor results showed that a sample drawn from the same donor on 12DEC2025 was negative for Ultrio Elite and Serology (HBs Ag). The archived sample was retested on (b)(6) 2026 with non repeat reactive results for Ultrio Elite, nonreactive HBV discriminatory results and positive results for Anti-HBc (negative Anti-HBs). A fresh draw from the donor was taken on (b)(6) 2026 and tested on Ultrio Elite in duplicate resulting in nonrepeat reactive results. The first sample tested positive at 17 IU/ml on qHBV PCR (Abbott Alinity) but negative with the second sample tested. The status of the blood donation drawn on (b)(6) 2025 and (b)(6) 2026 is pending. Summary of Customer Testing:(b)(6) 2025: Initial fresh drawUltrio Elite ML 710006S/CO, NonreactiveSerology (Abbott Alinity) HBsAg Nonreact

  Patient problems: Transfusion Reaction

  MAUDE report 50777945 ↗
• InjuryOct 15, 2025False Negative Result; False Negative Result

  IN JULY 2025, A LARGE POOL AND ONE CONSTITUENT WERE REACTIVE IN (b)(6). THE SAMPLE DID NOT DISCRIMINATE. A REFERENCE LAB QUANTIFIED THE SAMPLE AS 1.4 IU/ML HBV DNA.THE CUSTOMER DID A LOOK BACK AT TWO PREVIOUS DONATIONS IN JANUARY AND APRIL 2025 AND BOTH WERE NONREACTIVE IN UE. REFERENCE LAB ANALYSIS OF THE DONATIONS WERE NONREACTIVE AND REACTIVE, RESPECTIVELY. THE CUSTOMER REQUESTED AN EXPLANATION FOR THE DISCREPANT RESULTS.THE DONATION IN APRIL WAS TRANSFUSED IN MAY (RED BLOOD CELLS). THE RECIPIENT WAS TESTED FOR HBV DNA IN AUGUST, AND THE RESULT WAS NEGATIVE. NO RETESTING PLANNED.SEROLOGY FOR EACH DONATION WAS ANTI-HBC AND ANTI-HBS POSITIVE.TESTING SUMMARY:JULY DONATIONPOOL MAS10014185: UE R(b)(4) 25: UE R, DHIV/DHCV/DHBV NRREFERENCE LAB: HBV R AND HBV QUANTIFIED AT 1.4 IU/ML (ROCHE), ANTI-HBC TOTAL REACTIVE, ANTI-HBS POSITIVE, ANTI-HBC IGM NOT DETECTED.APRIL DONATIONPOOL MAS10053196: UE NR(b)(4) 25: UE NRREFERENCE LAB: ROCHE R FOR HBV, ANTI-HBC TOTAL REACTIVE, ANTI-HBS POSITIVE.JANUARY DONATIONPOOL MAS10075267: UE NR(b)(4) 25: UE NRREFERENCE LAB: ROCHE NR, ANTI-HBC TOTAL REACTIVE, ANTI-HBS POSITIVE.NO QUANTITATION AVAILABLE FOR APRIL AND JANUARY. JULY SAMPLE WAS CONFIRMED LOW TI

  Patient problems: Insufficient Information

  MAUDE report 23296862 ↗
• InjuryOct 6, 2025False Negative Result; False Negative Result

  ON 12SEP2025 GRIFOLS WAS NOTIFIED THAT THE NATIONAL BLOOD SERVICE ZIMBABWE IN ZIMBABWE TESTED SAMPLE ID (b)(6) ON (b)(6) 2025 USING ULTRIO ELITE ML 708074 SCREENING AND DISCRIMINATORY ASSAYS. ALL GAVE NONREACTIVE RESULTS. THE SAMPLE WAS ALSO SEROLOGY TESTED WITH THE FOLLOWING RESULTS: HBSAG POSITIVE, NEGATIVE FOR HIV COMBO AND ANTI-HCV. THE FOLLOWING IS A SUMMARY OF THE ULTRIO ELITE ML 708074 TESTING COMPLETED ON (b)(6) 2025 FOR SAMPLE ID (b)(6):ULTRIO ELITE NONREACTIVE WITH AN S/CO OF 0.06,ULTRIO ELITE DHBV NONREACTIVE WITH AN S/CO OF 0.00,ULTRIO ELITE DHCV NONREACTIVE WITH AN S/CO OF 0.00,ULTRIO ELITE DHIV NONREACTIVE WITH AN S/CO OF 0.12. THE FOLLOWING IS A SUMMARY OF THE SEROLOGY TESTING COMPLETED ON (b)(6) 2025 FOR SAMPLE ID (b)(6):HBSAG REACTIVE WITH AN S/CO 1.97,HBSAG REACTIVE WITH AN S/CO 1.91,HBSAG REACTIVE WITH AN S/CO 1.81,HIV COMBO NONREACTIVE WITH AN S/CO 0.08,ANTI0HCVII NONREACTIVE WITH AND S.CO OF 0.05.GRIFOLS IS WORKING WITH THE DISTRIBUTOR TO DETERMINE IF SAMPLE IS AVAILABLE FOR INVESTIGATIONAL TESTING IN ORDER TO COMPLETE QUANTIFICATION OF THE HBV VIRAL LOAD OF THE SAMPLE TO DETERMINE IF IT IS BELOW THE LIMIT OF DETECTION OF THE ULTRIO ELITE SCREENING AND DHBV ASS

  Patient problems: Insufficient Information

  MAUDE report 23223655 ↗
• InjuryAug 15, 2025False Negative Result; False Negative Result

  ON 17JUL2025, GRIFOLS CUSTOMER CREATIVE TESTING SOLUTIONS AZ (USE) REPORTED DISCREPANCY BETWEEN UE SCREENING AND DISCRIMINATORY TESTING. TESTING WAS PERFORMED IN (B)(6) 2025 USING MASTER LOT, PROCLEIX ULTRIO ELITE, MN 9051171, LN 708157. MASTER POOL SAMPLE (B)(6) TESTED REACTIVE FOR ULTRIO ELITE. ALL SAMPLES IN THE POOL WERE NONREACTIVE FOR UE IN IDT TESTING. IDT SAMPLE (B)(6) TESTED REACTIVE FOR DHBV DISCRIMINATORY TEST. ALINITY SEROLOGY RESULTS FOR IDT SAMPLE (B)(6) WERE ANTI-HBC (X2) REACTIVE AND HBSAG NONREACTIVE. THE DONATION WAS DEFERRED. SAMPLES WERE NOT AVAILABLE FOR INVESTIGATIONAL TESTING AT GRIFOLS. THE TESTING DATA IS SUMMARIZED BELOW: ULTRIO ELITE SAMPLE ID (B)(6). S/C0 7.92 REACTIVE IDT SAMPLE (B)(6) S/C0 0.11 NONREACTIVE. DHBV DT SAMPLE (B)(6) S/C0 14.13 REACTIVE. SEROLOGY: ALINITY (DONE ON (B)(6) 2025) ANTI-HBC 2X REACTIVE HBSAG NONREACTIVE HCV NONREACTIVE HIV NONREACTIVE. NO RELATED QUALITY EVENTS WERE FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA. A PREVIOUS EVENTS SEARCH DID NOT INDICATE A TREND FOR HBV SENSITIVITY ISSUES WITH ULTRIO ELITE ML 708157. THE ROOT CAUSE OF THE NONREACTIVE ULTRIO ELITE RESULT IS LIKELY LOW TITER HBV. INTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822234 ↗
• InjuryJan 24, 2025False Negative Result; False Negative Result

  ON (B)(6) 2024, GRIFOLS CUSTOMER GIFT OF HOPE (USA), REPORTED A DISCREPANT HBV RESULT FOR A DONOR SAMPLE TESTED WITH PROCLEIX ULTRIO ELITE ASSAY MASTER LOT (ML) 708074. THE INITIAL DONOR SAMPLE TESTED ON (B)(6) 2024 YIELDED A NONREACTIVE RESULT IN THE SCREENING ASSAY WITH AN S/CO OF 0.23 AND REACTIVE IN THE DISCRIMINATORY HBV ASSAY WITH AN S/CO OF 16.98. THE SAMPLE WAS ANTI-HBC REACTIVE AND HBSAG NONREACTIVE. THE DONATION WAS NOT USED AND REMAINING VOLUME OF THE PLASMA SAMPLE WAS SENT TO GRIFOLS FOR INVESTIGATIONAL TESTING. GRIFOLS TESTED THE SAMPLE IN THE APTIMA HBV QUANT ASSAY ON (B)(6) 2025. THE RESULTS FROM THE TWO REPLICATES WERE DISCORDANT: "HBV DNA NOT DETECTED" AND "20 IU/ML HBV DNA". NO RELATED QUALITY EVENTS WERE FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA. A PREVIOUS EVENTS SEARCH DID NOT INDICATE A TREND FOR HBV SENSITIVITY ISSUES WITH ULTRIO ELITE ML 708074. THE ROOT CAUSE OF THE NONREACTIVE ULTRIO ELITE RESULT IS LIKELY LOW TITER HBV. INTERMITTENT REACTIVITY IS EXPECTED AT CONCENTRATIONS AT OR BELOW THE LIMIT OF DETECTION OF THE ASSAY. THE SEROLOGICAL PROFILE IS CONSISTENT WITH OCCULT HBV INFECTION (OBI), WHICH IS MARKED BY LOW TO UNDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21235820 ↗
• InjuryJan 15, 2025False Negative Result; False Negative Result

  ON (B)(6) 2024, GRIFOLS DISTRIBUTOR (B)(4) (ON BEHALF OF CUSTOMER (B)(6), REPORTED A DISCREPANT HIV RESULT FOR A DONOR SAMPLE TESTED WITH PROCLEIX ULTRIO ELITE ASSAY MASTER LOT: (ML) 708054. THE INITIAL DONOR SAMPLE TESTED ON (B)(6) 2024 YIELDED A NONREACTIVE RESULT WITH AN S/CO OF 0.08. THE SAMPLE WAS HIV SEROLOGY POSITIVE IN THE DIASORIN ASSAY. THE DIASORIN RESULTS WERE DELETED FOR UNKNOWN REASONS. THE SAMPLE WAS SENT TO AN OFFSITE CLIA LABORATORY FOR ADDITIONAL TESTING. ON (B)(6) 2024, THE SAMPLE WAS FOUND NONREACTIVE IN THE ABBOTT ARCHITECT ANTI-HIV ASSAY. THE CUSTOMER ACCEPTED THE AGREEMENT BETWEEN PROCLEIX AND ABBOTT RESULTS (NONREACTIVE FOR HIV) AS THE VALID SAMPLE INTERPRETATION AND NO SAMPLE REMAINED FOR INVESTIGATION. NO RELATED QUALITY EVENTS FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA. A PREVIOUS EVENTS SEARCH DID NOT INDICATE A TREND FOR HIV SENSITIVITY ISSUES WITH ULTRIO ELITE ML 708054. THE ROOT CAUSE OF THE DISAGREEMENT BETWEEN THE ULTRIO ELITE AND ABBOTT RESULTS AS COMPARED TO THE DIASORIN RESULTS COULD NOT BE DETERMINED. FALSE POSITIVE RESULTS IN THE DIASORIN ASSAY DUE TO CONTAMINATION OR ASSAY PERFORMANCE COULD NOT BE RULED OUT. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164075 ↗
• InjuryJul 16, 2024False Negative Result; False Negative Result

  SAMPLE ID (B)(6) GRIFOLS CUSTOMER HAEMA AG (GERMANY) REPORTED ONE PLASMA SAMPLES THAT WAS NONREACTIVE IN A POOL OF 72 WHEN TESTED IN UE ML 707145 BUT WAS CONFIRMED HBSAG AND ANTI-HBC POSITIVE IN INDIVIDUAL DONOR TESTING (IDT). IT WAS NOT TESTED IDT IN UE. THE PLASMA SAMPLE WAS INITIALLY REACTIVE WHEN TESTED IN IDT IN DHBV, AND INTERMITTENTLY REACTIVE WHEN BOTH SERUM AND PLASMA WERE RETESTED IDT IN DHBV AS PART OF AN INTERNAL VALIDATION FOR SERUM AND PLASMA EQUIVALENCY. NO SAMPLE REMAINS FOR INVESTIGATION. RECORD STATES NO PATIENT AT RISK DUE TO REACTIVE HBV SEROLOGY. RELEASE TESTING: ON (B)(6) 2024: HBSAG REACTIVE (SERUM), ON (B)(6) 2024: ANTI-HBC REACTIVE (SERUM), ON (B)(6) 2024: P72 UE NONREACTIVE (EDTA), ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 23.00) (EDTA). INTERNAL VALIDATION TESTING: ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 24.01) (EDTA), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (SERUM), ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 21.52) (EDTA), ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 21.73) (SERUM), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA), ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 22.89) (SERUM), ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 20.75) (EDTA). NOTE: S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747614 ↗
• InjuryJul 16, 2024False Negative Result; False Negative Result

  SAMPLE ID (B)(6). GRIFOLS CUSTOMER HAEMA AG (GERMANY) REPORTED ONE PLASMA SAMPLES THAT WAS NONREACTIVE IN A POOL OF 96 WHEN TESTED IN UE ML 707145 BUT WAS CONFIRMED HBSAG AND ANTI-HBC POSITIVE IN INDIVIDUAL DONOR TESTING (IDT). IT WAS NOT TESTED IDT IN UE. THE PLASMA SAMPLE WAS INITIALLY REACTIVE WHEN TESTED IN IDT IN DHBV, AND INTERMITTENTLY REACTIVE WHEN BOTH SERUM AND PLASMA WERE RETESTED IDT IN DHBV AS PART OF AN INTERNAL VALIDATION FOR SERUM AND PLASMA EQUIVALENCY. NO SAMPLE REMAINS FOR INVESTIGATION. RECORD STATES NO PATIENT AT RISK DUE TO REACTIVE HBV SEROLOGY. RELEASE TESTING: ON (B)(6) 2024: HBSAG REACTIVE (SERUM). ON (B)(6) 2024: ANTI-HBC REACTIVE (SERUM) ON (B)(6) 2024: P96 UE NONREACTIVE (EDTA). ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 23.01) (EDTA NAT). INTERNAL VALIDATION TESTING: ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA IH), ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 23.02) (SERUM), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA NAT), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA IH), ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 2.14) (SERUM), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA NAT), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747581 ↗
• InjuryJun 1, 2024False Negative Result; False Negative Result

  ON 02MAY2024, GRIFOLS CUSTOMER (B)(6) HOSPITAL IN PAKISTAN REPORTED ONE SAMPLE (ID (B)(6)) THAT WAS HBSAG SEROLOGY REACTIVE AND ULTRIO ELITE SCREENING AND DHBV NONREACTIVE. TESTING SUMMARY: (B)(6) 2024 ANTI-HCV NONREACTIVE (S/CO 0.12). (B)(6) 2024 HIV AG/AB NONREACTIVE (S/CO 0.19). (B)(6) 2024 HBSAG REACTIVE X2 (S/CO 1.20, 1.33 S/CO). (B)(6) 2024 HBSAG CONFIRMATORY REACTIVE (S/CO 5.04). (B)(6) 2024 HBSAG NEUTRALIZATION 98.4307%. (B)(6) 2024 UE SCREENING NONREACTIVE (S/CO 0.11) ML 707983. (B)(6) 2024 UE DHBV NONREACTIVE (S.CO 0.01) ML 707983. DATE UNKNOWN PCR ROCHE COBAS HBV: <10 IU/ML. SEROLOGY AND NAT/PCR TESTING WERE PERFORMED FROM DIFFERENT TUBES. NAT AND PCR TESTING WERE PERFORMED FROM THE SAME TUBE. THE DONATION WAS FROM A NEW DONOR WHO WAS CLEARED BASED ON THEIR UNIVERSAL DONOR HISTORY QUESTIONNAIRE. THE DONATION WAS NOT USED FOR TRANSFUSION. GRIFOLS REQUESTED THE RESULTS OF ANY ANTI-HBC SEROLOGY TESTING, BUT THAT WAS NOT PERFORMED. THE SITE ALSO PERFORMED HBV QUANTITATIVE TESTING ON THE NAT TESTING TUBE (PLASMA, K3EDTA) USING A ROCHE COBAS PCR TEST (ADDITIONAL DETAILS NOT PROVIDED) AND THE RESULTS WERE HBV DETECTED AT <10 IU/ML. THE CUSTOMER PROVIDED THE ULTRIO ELITE SCREENI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442925 ↗
• InjuryJun 1, 2024False Negative Result; False Negative Result

  ON 02MAY2024, GRIFOLS CUSTOMER (B)(6) IN PAKISTAN REPORTED ONE SAMPLE (B)(6) THAT WAS HBSAG SEROLOGY REACTIVE AND ULTRIO ELITE SCREENING AND DHBV NONREACTIVE. FOLLOW UP UE DHBV TESTING IN DUPLICATE FROM A NEW TUBE DRAWN FROM THE FFPE BAG WAS REACTIVE. TESTING SUMMARY: (B)(6) 2024 ANTI-HCV NONREACTIVE (S/CO 0.12) (B)(6) 2024 HIV AG/AB NONREACTIVE (S/CO 0.13) (B)(6) 2024 HBSAG REACTIVE (S/CO 1506.33) (B)(6) 2024 HBSAG REACTIVE (S/CO 1550.41) (B)(6) 2024 HBSAG NEUTRALIZATION 96.1287% (B)(6) 2024 ROCHE COBAS PCR HBV DETECTED AT <10 IU/ML. (B)(6) 2024 UE SCREENING NONREACTIVE (S/CO 0.06) ML 707983 (B)(6) 2024 UE DHBV NONREACTIVE (S.CO 0.21) ML 707983 (B)(6) 2024 UE DHBV REACTIVE X2 (S/CO 24.07, 22.94) ML 707983 SEROLOGY AND NAT TESTING WERE PERFORMED FROM DIFFERENT TUBES. NAT AND PCR WERE PERFORMED ON THE SAME TUBE. THE DONATION WAS FROM A NEW DONOR WHO WAS CLEARED BASED ON THEIR UNIVERSAL DONOR HISTORY QUESTIONNAIRE. THE DONATION WAS NOT USED FOR TRANSFUSION. GRIFOLS REQUESTED THE RESULTS OF ANY ANTI-HBC SEROLOGY TESTING, BUT THAT WAS NOT PERFORMED. ON (B)(6) 2024 THE SITE ALSO PERFORMED HBV QUANTITATIVE TESTING ON THE NAT TESTING TUBE (PLASMA, K3EDTA) USING A ROCHE COBAS PCR TEST (ADD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442722 ↗
• InjuryMar 14, 2024False Negative Result; False Negative Result

  ON 15FEB2024, GRIFOLS CUSTOMER, GRIFOLS CUSTOMER ARMED FORCES INSTITUTE OF TRANSFUSION (PAKISTAN) REPORTED ONE SAMPLE THAT WAS NONREACTIVE WITH ULTRIO ELITE (UE) AND SEROLOGY (ASSAYS UNKNOWN) BUT WAS REACTIVE FOR HBV IN "ROCHE 6800". FRESH FROZEN PLASMA FROM THE SAME DONATION WAS RETESTED IN UE (NONREACTIVE) AND ROCHE (REACTIVE).THE CUSTOMER REQUESTED AN EXPLANATION FOR THE DISCORDANT RESULTS. DUE TO THE REACTIVE RESULT FROM THE ROCHE, THE DONATION WAS NOT USED. NO SAMPLE REMAINS FOR INVESTIGATION. A PREVIOUS EVENTS SEARCH FOR HBV SENSITIVITY ISSUES ACROSS ALL UE MASTER LOTS WAS PERFORMED AND NO TRENDS WERE IDENTIFIED THAT INDICATED A LOSS OF SENSITIVITY IN ANY UE REAGENT MASTER LOT. A RISK ASSESSMENT WAS PERFORMED. THE SEVERITY OF A BLOOD SCREENING FALSE NEGATIVE RESULT IS CRITICAL, AS USE OF AN INFECTED DONATION CAN CAUSE MULTIPLE INFECTIONS. THE PROBABILITY OF A FALSE NEGATIVE RESULT IS REMOTE BASED ON THE PREVIOUS EVENTS SEARCH. FALSE NEGATIVE RESULTS DO OCCUR BUT ARE RARE. FOLLOWING ISO 14971, GRIFOLS RISK ASSESSMENT IS BASED ON SEVERITY OF A HARM OR IMPACT TO HUMAN HEALTH AND THE PROBABILITY OF OCCURRENCE OF HARM OR IMPACT TO HUMAN HEALTH. BASED ON THE SEVERITY RATING OF 'CRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909141 ↗
• InjuryMar 1, 2024False Negative Result; False Negative Result

  CUSTOMER KING ABDULAZIZ UNIVERSITY (SAUDI ARABIA) REPORTED ON 05FEB2024 INITIAL ULTRIO ELITE NONREACTIVE RESULTS FOR DONOR SAMPLE USING LN 706570. SEROLOGY RESULTS WERE REACTIVE FOR HBSAG AND ANTI-HBC. DISCRIMINATORY DHBV TESTS WERE REACTIVE. REPEAT UE TEST USING SAME TUBE WAS REACTIVE. DONOR ADMITTED TO HAVING HBV. DONATION WAS NOT USED FOR TRANSFUSION. NO REMAINING SAMPLE WAS AVAILABLE FOR INVESTIGATION. SUMMARY OF TESTING: (B)(6) 2024. SAMPLE (B)(6) RESULTS: ULTRIO ELITE NONREACTIVE S/CO 0.12. SAMPLE (B)(6) (SEROLOGY TUBE FROM THE SAME DONOR) RESULTS: HBSAG REACTIVE (3 REPLICATES) ANTI-HBC REACTIVE (3 REPLICATES). 22JAN2024. SAMPLE 1109634 (SEROLOGY TUBE FROM THE SAME DONOR) RESULTS: ULTRIO ELITE REACTIVE S/CO 12.34. DHBV REACTIVE S/CO 23.49. IN ADDITION, THE CUSTOMER INDICATED THAT PCR TESTING TOOK PLACE IN (B)(6) 2023. IN THIS PARTICULAR CASE, NAT AND SEROLOGY WERE CARRIED OUT ON (B)(6) 2024. SINCE THE CONVENTIONAL PRACTICE INVOLVES CONDUCTING PCR AS A CONFIRMATORY TEST FOLLOWING NAT AND SEROLOGY, IT IS HIGHLY PROBABLE THAT THE PCR TESTED A SAMPLE OBTAINED FROM A PRIOR DRAW. CONSEQUENTLY, THE PCR OUTCOME FROM (B)(6) 2023 WILL NOT BE CONSIDERED IN ASSESSING THE PERFORMANCE OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822857 ↗
• InjuryOct 10, 2023False Negative Result; False Negative Result

  ON (B)(6) 2023, (B)(6) REPORTED ONE PLASMA POOL (8 DONORS) THAT WAS NONREACTIVE WITH ULTRIO ELITE ML 704639, BUT INDIVIDUAL DONOR TESTING (IDT) SHOWED ONE POOL MEMBER WAS REACTIVE IN BOTH UE AND DHBV, AND POSITIVE IN BOTH HBSAG AND ANTI-HBC. THE CUSTOMER INITIALLY QUESTIONED WHY THE POOLED SAMPLE WAS NONREACTIVE AND IDT WAS REACTIVE, BUT NOW UNDERSTANDS THE SENSITIVITY DIFFERENCE BETWEEN A POOL AND IDT. THE DONATION WAS DISCARDED BEFORE USE. NO SAMPLE VOLUME REMAINED FOR INVESTIGATION. RELEVANT TESTS: POOL NAT ON (B)(6) 2023: POOL (MAS5934) UE NONREACTIVE (S/CO 0.07). IDT SEROLOGY: ON (B)(6) 2023: IDT (B)(4) ANTI-HBC POSITIVE. ON (B)(6) 2023: IDT (B)(4) HBSAG POSITIVE. IDT NAT: ON (B)(6) 2023: IDT (B)(4) UE REACTIVE (S/CO 13.89). ON (B)(6) 2023: IDT (B)(4) DHIV NONREACTIVE (S/CO 0.09, 0.04). ON (B)(6) 2023: IDT (B)(4) DHCV NONREACTIVE (S/CO INVALID, 0.00). ON (B)(6) 2023: IDT (B)(4) DHBV REACTIVE (S/CO 24.53, 24.88). NO POSITIVE RESULTS WERE REPORTED TO GRIFOLS FOR THE OTHER 7 POOL MEMBERS. RISK ANALYSIS: SEVERITY: CRITICAL. A SINGLE BLOOD SCREENING FALSE NEGATIVE (FN) RESULT CAN CAUSE MULTIPLE INFECTIONS. THE SEVERITY OF A BLOOD SCREENING FALSE NEGATIVE IS CRITICAL. PROBABILITY: R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909401 ↗
• InjurySep 29, 2023False Negative Result; False Negative Result

  ON (B)(6) 2023, GRIFOLS CUSTOMER DONOR SERV LABORATORY (B)(6)) REPORTED A DISCREPANT HBV RESULT FOR ORGAN DONOR SERUM SAMPLE (B)(6). THE SAMPLE WAS NONREACTIVE (S/CO 0.12) WITH ULTRIO ELITE (UE) MASTER LOT (ML) 706037 WHEN DILUTED 1:5, AND REACTIVE FOR HBSAG IN 3/4 REPS. THE SAMPLE WAS DILUTED PRIOR TO UE TESTING DUE TO A HIGH LEVEL OF HEMOLYSIS, PER INSTRUCTIONS IN THE UE PACKAGE INSERT. THE CUSTOMER QUESTIONED ULTRIO ELITE HBV SENSITIVITY. IT IS UNKNOWN IF ORGAN WAS USED FOR TRANSPLANT. RELEVANT TESTS FOR SAMPLE (B)(6). NAT. (B)(6) 2023: DILUTED SAMPLE ULTRIO ELITE NONREACTIVE (S/CO 0.06) SEROLOGY (B)(6) 2023: HBSAG EIA 30 REACTIVE. (B)(6) 2023: HBSAG EIA 30 NONREACTIVE. (B)(6) 2023: HBSAG EIA 30 REACTIVE. (B)(6) 2023: HBSAG EIA 30 REACTIVE. (B)(6) 2023: OD HBC ELISA NONREACTIVE. (B)(6) 2023: GS HIV 1+2 PLUS O EIA NONREACTIVE. (B)(6) 2023: OD HCV 30 ELISA NONREACTIVE. INVESTIGATION: SAMPLE VOLUME WAS RETURNED FOR INVESTIGATION, RECEIVED ON (B)(6) 2023 2023 FOR HBV QUANTITATION USING APTIMA HBV QUANT ASSAY. THE PROCLEIX ULTRIO ELITE INSTRUCTIONS FOR USE (IFU) GDSS-IFU-000006 V.9.0 SPECIFIES "DO NOT FREEZE WHOLE BLOOD". THE APTIMA HBV QUANT ASSAY IFU AW-15644, REV.002 SPECIFIES "DO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17846329 ↗
• InjuryJun 23, 2023False Negative Result; False Negative Result

  ON (B)(6) 2023, A REPRESENTATIVE FOR KUWAIT CENTRAL BLOOD BANK IN KUWAIT REPORTED DISCORDANT HBV RESULTS BETWEEN DIFFERENT TESTING METHODS FOR A SERUM SAMPLE (K55012303447100) USED TO SCREEN A PLASMA DONATION. THE ULTRIO ELITE SCREENING ASSAY (UE) AND HIV, HCV, AND HBV DISCRIMINATORY ASSAYS (DHIV, DHCV, AND DHBV, RESPECTIVELY) USED ULTRIO ELITE MASTER LOT (ML) 704982. TESTING RESULTS ARE AS FOLLOWS: (B)(6) 2023: ANTI-HBC POSITIVE. (B)(6) 2023: HBSAG NONREACTIVE. (B)(6) 2023: ROCHE COBAS MPX HBV REACTIVE. (B)(6) 2023: UE NONREACTIVE S/CO 0.08. (B)(6) 2023: DHBV NONREACTIVE S/CO 0.00. (B)(6) 2023: UE DHIV NONREACTIVE S/CO 0.09. 0.07. (B)(6) 2023: UE DHCV NONREACTIVE S/CO 0.00. THE DONATION WAS BLOCKED FROM USE BASED ON THE ROCHE REACTIVE RESULT. THE ULTRIO ELITE ASSAY AND DISCRIMINATORY ASSAYS WERE USED AS CONFIRMATION OF THE ROCHE RESULT. GRIFOLS REQUESTED RETURN OF THE REMAINING SAMPLE VOLUMES TO GRIFOLS SAN DIEGO FOR INVESTIGATIONAL HBV QUANTITATIVE TESTING BUT THE CUSTOMER WAS UNABLE TO RETURN THE SAMPLES. THE ROOT CAUSE OF THE NONREACTIVE ULTRIO ELITE RESULT COULD NOT BE DETERMINED. ALTHOUGH THE NONREACTIVE RESULTS COULD BE DUE TO THE SAMPLE HBV CONCENTRATION BEING AT OR BELOW T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195224 ↗
• InjuryJun 19, 2023False Negative Result; False Negative Result

  ON 24MAY2023, A REPRESENTATIVE FOR (B)(6) BLOOD BANK IN KUWAIT REPORTED DISCORDANT HBV RESULTS BETWEEN DIFFERENT TESTING METHODS FOR A SERUM SAMPLE (K55012320227000) USED TO SCREEN A PLASMA DONATION. THE ULTRIO ELITE SCREENING ASSAY (UE) AND HIV, HCV, AND HBV DISCRIMINATORY ASSAYS (DHIV, DHCV, AND DHBV, RESPECTIVELY) USED ULTRIO ELITE MASTER LOT (ML) 704982. TESTING RESULTS ARE AS FOLLOWS: (B)(6) 2023: ANTI-HBC POSITIVE; (B)(6) 2023: HBSAG NONREACTIVE; (B)(6) 2023: ROCHE COBAS MPX HBV REACTIVE; (B)(6) 2023: UE NONREACTIVE S/CO 0.10; (B)(6) 2023: DHBV REACTIVE S/CO 20.63; (B)(6) 2023: UE DHIV NONREACTIVE S/CO 0.07; (B)(6) 2023: UE DHCV NONREACTIVE S/CO 0.00. THE DONATION WAS BLOCKED FROM USE BASED ON THE ROCHE REACTIVE RESULT. THE ULTRIO ELITE ASSAY AND DISCRIMINATORY ASSAYS WERE USED AS CONFIRMATION OF THE ROCHE RESULT. AN INVESTIGATION IS ONGOING FOR THE DISCORDANT HBV RESULT. REMAINING SAMPLE WAS REQUESTED TO BE RETURNED TO GRIFOLS FOR FURTHER EVALUATION INCLUDING 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 I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159667 ↗
• InjuryJun 19, 2023False Negative Result; False Negative Result

  ON 24MAY2023, A REPRESENTATIVE FOR KUWAIT CENTRAL BLOOD BANK IN KUWAIT REPORTED DISCORDANT HBV RESULTS BETWEEN DIFFERENT TESTING METHODS FOR A SERUM SAMPLE (B)(4). USED TO SCREEN A PLASMA DONATION. THE ULTRIO ELITE SCREENING ASSAY (UE) AND HIV, HCV, AND HBV DISCRIMINATORY ASSAYS (DHIV, DHCV, AND DHBV, RESPECTIVELY) USED ULTRIO ELITE MASTER LOT (ML) 704982. TESTING RESULTS ARE AS FOLLOWS: (B)(6)2023: ANTI-HBC POSITIVE (B)(6)2023: ROCHE COBAS MPX HBV REACTIVE (B)(6)2023: UE NONREACTIVE S/CO 0.07 (B)(6) 2023: DHBV REACTIVE S/CO 1.19 (B)(6) 2023: UE DHIV NONREACTIVE S/CO 0.07 (B)(6) 2023: UE DHCV NONREACTIVE S/CO 0.00 THE DONATION WAS BLOCKED FROM USE BASED ON THE ROCHE REACTIVE RESULT. THE ULTRIO ELITE ASSAY AND DISCRIMINATORY ASSAYS WERE USED AS CONFIRMATION OF THE ROCHE RESULT. AN INVESTIGATION IS ONGOING FOR THE DISCORDANT HBV RESULT. REMAINING SAMPLE WAS REQUESTED TO BE RETURNED TO GRIFOLS FOR FURTHER EVALUATION INCLUDING 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159556 ↗
• InjuryMay 31, 2023False Negative Result; False Negative Result

  ON 04MAY2023, A REPRESENTATIVE FOR KUWAIT CENTRAL BLOOD BANK IN KUWAIT REPORTED DISCORDANT HBV RESULTS BETWEEN DIFFERENT TESTING METHODS FOR A SERUM SAMPLE USED TO SCREEN A PLASMA DONATION. THE ULTRIO ELITE SCREENING ASSAY (UE) AND HIV, HCV, AND HBV DISCRIMINATORY ASSAYS (DHIV, DHCV, AND DHBV, RESPECTIVELY) USED ULTRIO ELITE MASTER LOT (ML) 704982. TESTING RESULTS ARE AS FOLLOWS: (B)(6) 2023: ANTI-HBC: POSITIVE. (B)(6) 2023: UE NONREACTIVE; S/CO 0.16. (B)(6) 2023: DHBV REACTIVE, S/CO 4.76. (B)(6) 2023: UE DHIV NONREACTIVE (S/CO 0.08). (B)(6) 2023: UE DHCV NONREACTIVE (S/CO 0.00). (B)(6) 2023: ULTRIO ELITE SCREENING NONREACTIVE (S/CO 0.12), CONFIRMATION IS PENDING DATE UNKNOWN: ROCHE COBAS MPX HBV REACTIVE, ADDITIONAL DETAILS PENDING. THE SITE NOTED THAT THIS IS A KNOWN DONOR WHO WAS POSITIVE FOR ANTI-HBC IN 2004 AND 2006. THE DONATION WAS BLOCKED FROM USE. AN INVESTIGATION IS ONGOING FOR THE DISCORDANT HBV RESULT. REMAINING SAMPLE IS BEING RETURNED TO GRIFOLS FOR FURTHER EVALUATION INCLUDING 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 REL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035485 ↗
• InjuryMay 26, 2023False Negative Result; False Negative Result

  ON (B)(6) 2023 GRIFOLS CUSTOMER, (B)(6), REPORTED A NONREACTIVE RESULT FOR A POOL OF 4 (P4) THAT CONTAINED A DONOR SAMPLE (B)(4) THAT WAS CONFIRMED HCV POSITIVE BASED ON ADDITIONAL TESTING. THE FOLLOWING IS A SUMMARY OF THE TESTING COMPLETED FOR THE DONOR IN THE FOLLOWING FORMAT: TESTING DATE, SAMPLE, TESTING METHOD, AND RESULT. TESTING WAS COMPLETED IN THE INDIVIDUAL DONOR SAMPLE UNLESS OTHERWISE NOTED. ON (B)(6) 2023, NAT PRIMARY TUBE IN P4, ULTRIO ELITE SCREENING, NONREACTIVE (S/CO 0.12). ON (B)(6) 2023, SEROLOGY PRIMARY TUBE (B)(4), ANTI-HCV, POSITIVE. ON (B)(6) 2023, PLASMA BAG, ANTI-HCV**, POSITIVE. ON (B)(6) 2023, NAT PRIMARY TUBE (B)(4), IB / HCV, POSITIVE. ON (B)(6) 2023, SEROLOGY PRIMARY TUBE (B)(4), IB / HCV, POSITIVE. ON (B)(6) 2023, ARCHIVE FROM NAT PRIMARY TUBE (B)(4), IB / HCV, POSITIVE. ON (B)(6) 2023, SEROLOGY SECONDARY TUBE (FROZEN) (B)(4), ULTRIO ELITE SCREENING, REACTIVE (S/CO 8.48). ON (B)(6) 2023, SEROLOGY SECONDARY TUBE (FROZEN) (B)(4), ULTRIO ELITE DHCV, REACTIVE (S/CO 23.71). ON (B)(6) 2023, SEROLOGY SECONDARY TUBE (FROZEN) IN P4 WITH (B)(4) AND 3 KNOWN NEGATIVE SAMPLES, ULTRIO ELITE SCREENING, REACTIVE (S/CO 7.39). ON (B)(6) 2023, SEROLOGY SECONDARY TUBE (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17012080 ↗
• InjuryApr 14, 2023False Negative Result; False Negative Result

  ON 21MAR2023, A REPRESENTATIVE FOR KUWAIT CENTRAL BLOOD BANK IN KUWAIT REPORTED DISCORDANT TESTING RESULTS BETWEEN DIFFERENT TESTING METHODS FOR A PLASMA SAMPLE FROM A BLOOD DONOR. TESTING RESULTS ARE AS FOLLOWS: (B)(6) 2023: ROCHE COBAS HBV REACTIVE, ADDITIONAL DETAILS PENDING (B)(6) 2023: ULTRIO ELITE SCREENING NR; S/CO 0.10; RLU 10,515 WITH ML 704982 SEROLOGY WAS COMPLETED AROUND THE SAME TIME, BUT EXACT DATES ARE PENDING: HBSAG: NEGATIVE ANTI-HBC: POSITIVE THE SITE NOTED THAT THIS IS A KNOWN DONOR WHO WAS TESTED 6 OR 7 MONTHS AGO AND WAS POSITIVE FOR ANTI-HBC AND HBV NAT AT THAT TIME. GRIFOLS HAS REQUESTED ADDITIONAL DETAILS RE: WHICH NAT TESTING WAS PERFORMED AT THAT TIME AND THE TESTING DATES. THE DONATION AND DONOR HAVE BEEN BLOCKED. THE CUSTOMER HAS 2ML OF SAMPLE AVAILABLE FOR INVESTIGATIONAL TESTING AT GRIFOLS. GRIFOLS IS CURRENTLY ARRANGING SHIPMENT OF THE MATERIAL TO GRIFOLS SAN DIEGO FOR HBV QUANTITATIVE TESTING. DELIVERY DATE OF SAMPLE IS PENDING. 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 TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747996 ↗
• InjuryNov 11, 2022False Negative Result; False Negative Result

  ON 19OCT2022, GRIFOLS DISTRIBUTOR (B)(4) REPORTED A DONATION WAS NONREACTIVE WITH THE PROCLEIX ULTRIO ELITE ASSAY (ML 704639). IT WAS NOT TESTED IN THE DISCRIMINATORY ASSAYS. THE DONATION WAS HBV SEROLOGY POSITIVE FOR HBSAG AND ANTI-HBC. IT WAS ALSO HBV PCR REACTIVE IN A ROCHE QUALITATIVE ASSAY. THE DONATION WAS ALSO POSITIVE FOR MALARIA. THE DONATION WAS NOT USED, AND NO SAMPLE VOLUME REMAINS FOR INVESTIGATION. NO MEDICAL HISTORY IS AVAILABLE. THE TESTING DATA IS SUMMARIZED BELOW: (B)(6) 2022 ULTRIO ELITE NONREACTIVE. (B)(6) 2022 ANTI-HBC POSITIVE. (B)(6) 2022 ANTI-HBS NEGATIVE. (B)(6) 2022 HBSAG POSITIVE. (B)(6) 2022 HBV PCR REACTIVE (ROCHE). A REVIEW OF THE QUALITY CONTROL DATA FOR ULTRIO ELITE ML 704639 WAS PERFORMED. THERE WERE NO RELATED QUALITY EVENTS FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA, AND NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THIS TYPE OF HBV SENSITIVITY ERROR IN THE ULTRIO ELITE ASSAY FOR ML 704639 OVER THE LAST YEAR. THE ROOT CAUSE OF THE FALSE NEGATIVE RESULT COULD NOT BE CONFIRMED DUE TO LACK OF SAMPLE FOR INVESTIGATION. INTERMITTENT REACTIVE RESULTS ARE EXPECTED IN LOW TITER SAMPLES (BELOW THE 95% LOD OF THE UE ASSAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15784167 ↗
• InjuryNov 11, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022, GRIFOLS DISTRIBUTOR (B)(4) CENTRAL BLOOD BANK (B)(4) REPORTED A DONATION WAS NONREACTIVE WITH THE PROCLEIX ULTRIO ELITE ASSAY (ML 704639). IT WAS NOT TESTED IN THE DISCRIMINATORY ASSAYS. THE DONATION WAS HIV SEROLOGY COMBO POSITIVE AND ANTI-HIV POSITIVE. IT WAS ALSO HIV PCR REACTIVE IN ROCHE 6800 HIV-1/2 QUALITATIVE ASSAY. THE DONATION WAS NOT USED, AND NO SAMPLE VOLUME REMAINS FOR INVESTIGATION. NO MEDICAL HISTORY IS AVAILABLE. THE TESTING DATA IS SUMMARIZED BELOW: ON (B)(6) 2022: ULTRIO ELITE NONREACTIVE. ON (B)(6) 2022: HIV COMBO POSITIVE (P24 AG/AB). ON (B)(6) 2022: ANTI-HIV POSITIVE. ON (B)(6) 2022: HIV-1/HIV-2 PCR REACTIVE (ROCHE 6800 HIV-1 HIV-2 QUAL ASSAY). A REVIEW OF THE QUALITY CONTROL DATA FOR ULTRIO ELITE ML 704639 WAS PERFORMED. THERE WERE NO RELATED QUALITY EVENTS FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA, AND NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THIS TYPE OF HIV SENSITIVITY ERROR IN THE ULTRIO ELITE ASSAY FOR ML 704639 OVER THE LAST YEAR. THE ROOT CAUSE OF THE FALSE NEGATIVE RESULT COULD NOT BE CONFIRMED DUE TO LACK OF SAMPLE FOR INVESTIGATION. INTERMITTENT REACTIVE RESULTS ARE EXPECTED IN LOW TITER SAMPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781508 ↗