Procleix Ultrio Plus Assay 5K Kit Box 1Recalls & reported problems
Grifols Diagnostic Solutions Inc.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859882007108), received between Mar 10, 2023 and Mar 10, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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
Device problems
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2023False Negative Result; False Negative Result
ON (B)(6)2022, A REPRESENTATIVE FROM (B)(6) CHINA REPORTED DISCORDANT TESTING RESULTS BETWEEN THE PROCLEIX ULTRIO PLUS ASSAY AND SEROLOGY FOR A PLASMA SAMPLE FROM A BLOOD DONOR. THE SAMPLE WAS TESTED TWICE ON ULTRIO PLUS MASTER LOT (ML) 706154 AND THE FOLLOWING RESULTS WERE REPORTED: TESTING DATE: (B)(6)2023, TESTING RESULT: NONREACTIVE, S/CO 0.23, RLU 21,926 . TESTING DATE: (B)(6)2023, TESTING RESULT: NONREACTIVE, S/CO 0.11, RLU 11,288. SEROLOGY TESTING WAS ALSO COMPLETED AND THE FOLLOWING RESULTS WERE REPORTED: TESTING DATE: (B)(6) 2023, TESTING METHOD: XC HIV AG-AB, TESTING RESULT: REACTIVE, S/CO 3.77 TESTING DATE (B)(6)2023, TESTING METHOD: BIO-RAD HIV AG-AB, TESTING RESULT: REACTIVE, S/CO 10.00 FOLLOWING INITIAL ULTRIO PLUS AND SEROLOGY TESTING, THE SAMPLE WAS SENT TO THE CHINESE CDC AND TESTED USING THEIR WESTERN BLOT HIV-AB TEST AND THE FOLLOWING RESULTS WERE REPORTED: TESTING DATE: NOT PROVIDED, TESTING RESULT: REACTIVE . THE DONATION WAS BLOCKED FOR USE. GRIFOLS REQUESTED THE ULTRIO PLUS RUN REPORTS FOR REVIEW BUT THE LAB DECLINED, CITING DONOR PRIVACY. A PREVIOUS EVENT SEARCH IN THE GRIFOLS COMPLAINT SYSTEM FOR OTHER ULTRIO PLUS HIV SENSITIVITY ISSUES WAS COMPLETED FOR TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16526898 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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