Procleix NAT Manager 1.2Recalls & reported problems
Biomedical Data Solutions Limited · Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports. · Class 2
Data updated Oct 16, 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 05060496770011), received between May 16, 2024 and May 16, 2024 — 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 16, 2026.
Reports received per month
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.
InjuryMay 16, 2024False Negative Result; False Negative Result
THE PROCLEIX PARVO/HAV ASSAY IS PERFORMING AS EXPECTED IN THIS EVENT. THIS REPORT PERTAINS TO THE MALFUNCTION OF THE PROCLEIX NAT MANAGER, THE MIDDLEWARE USED WITH THE PROCLEIX PARVO/HAV ASSAY ON PANTHER. BIOMEDICAL DATA SOLUTIONS LIMITED IS THE LEGAL MANUFACTURER OF THE PROCLEIX NAT MANAGER, AND GRIFOLS ACTS AS ITS DISTRIBUTOR. ON 16APR2024, GRIFOLS CUSTOMER (KREVNÍ CENTRUM ODBEROVÉ MÍSTO, CZECH REPUBLIC) REPORTED THAT A PARVO REACTIVE SAMPLE WAS RELEASED AS A NEGATIVE SAMPLE IN THE PROCLEIX NAT MANAGER. THE CUSTOMER DETECTED THAT THE SAMPLE WAS REACTIVE AND DID NOT RELEASE IT FOR TRANSFUSION. THE SAMPLE WAS CORRECTLY REPORTED AS '>100,000' FOR PARVO B19 BY PANTHER. HOWEVER, THE PANTHER/ PROCLEIX NAT MANAGER REPORTS FAILED TO MARK THE CEC (CONCENTRATION EQUAL TO OR EXCEEDED CUTOFF) FLAG FOR THIS SAMPLE, PANTHER DID NOT HIGHLIGHT THE SAMPLE IN THE RIGHT FORMAT, AND ALTHOUGH PROCLEIX NAT MANAGER CORRECTLY DISPLAYED THE REPORTED CONCENTRATION AS '>100,000', IT DISPLAYED THE MEASURED CONCENTRATION AS '-1' AND THE CONCLUSION AS 'BC' (BELOW CUTOFF). SEQUENCE OF EVENTS: ON PANTHER REPORT: PARVO IU/ML: >100, 000 FLAGS: NONE (MISSING CEC FLAG) NOT HIGHLIGHTED. ON PROCLEIX NAT MANAGER REPOR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19337926 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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