Stat Profile Prime Plus (REF 61615)Recalls & reported problems
Nova Biomedical Corporation · Stat Profile Prime Plus MicroSensor Card™ with COOX · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00385480616157), received between May 21, 2026 and May 21, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Calibrate” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Calibrate1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Failure to Calibrate
CUSTOMER SAID CARD HAS BEEN READING 0% SINCE (B)(6) 2026. THEY HAVE NOT BEEN ABLE TO RUN ANY SAMPLES SINCE (B)(6) 2026 AND DID NOT HAVE A BACKUP SENSOR CARD. A PATIENT WAS REROUTED BECAUSE THE SENSOR CARD COULD NOT BE BROUGHT UP TO USE OR REPLACED.
Patient problems: Insufficient Information
MAUDE report 25243493 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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