Procleix Ultrio Elite AssayRecalls & reported problems across all models
Grifols Diagnostic Solutions Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls
- 0
We found 3 models of Procleix Ultrio Elite Assay by Grifols Diagnostic Solutions Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Sep 23, 2021 and Sep 15, 2026 — classified as 37 injuries.
The most frequently reported specific device problem is “False Negative Result” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Procleix Ultrio Elite Assay problems
Device problems
- False Negative Result35
- Incorrect, Inadequate or Imprecise Result or Readings2
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information7
- Hepatitis4
- Transfusion Reaction1
Procleix Ultrio Elite Assay models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 22 reports
- 8 reports
- 7 reports
Recent Procleix Ultrio Elite Assay adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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