PAXgene® Blood RNA Tube 762165Recalls & reported problems
PreAnalytiX GmbH · TUBE RNA PLH 16X100 2.5 PLBLCE CLR · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This PAXgene Blood RNA tube from PreAnalytiX is a blood collection tube for RNA stabilization. The FDA records hold 96 reports, with no deaths and no injuries; many describe leaks, contamination or cracks in the tubes, and reports say there was no adverse impact on patients or users. Reports fell to 6 in the last 12 months from 14 in the prior 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 96
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 04053727621658), received between Oct 26, 2017 and Aug 18, 2026 — classified as 96 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (18 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash18
- Device Contamination with Chemical or Other Material16
- Incorrect, Inadequate or Imprecise Result or Readings10
- Crack8
- Device Ingredient or Reagent Problem8
- Break7
- Short Fill7
- Coagulation in Device or Device Ingredient6
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- No Known Impact Or Consequence To Patient25
- No Consequences Or Impact To Patient3
- No Information2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Device Ingredient or Reagent Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50309162 ↗MalfunctionAug 12, 2026Device Ingredient or Reagent Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225672 ↗MalfunctionMay 1, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO USING PAXGENE® BLOOD RNA TUBE, A FOREIGN OBJECT WAS FOUND INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056838 ↗MalfunctionMar 31, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBE, ONE TUBE CRACKED AND BROKE DURING THE THAWING PROCESS, RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749707 ↗MalfunctionMar 23, 2026Leak/Splash
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBE, ONE TUBE CRACKED AND BROKE DURING THE THAWING PROCESS, RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662044 ↗MalfunctionFeb 9, 2026Crack
IT WAS REPORTED PRIOR TO USING PAXGENE® BLOOD RNA TUBE, SEVEN (7) TUBES WERE FOUND TO HAVE CRACKS IN THE TUBE WALL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300301 ↗MalfunctionOct 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBE, HIGH RNA YIELDS (UP TO 600NG/UL) WERE ISOLATED FROM 28 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367912 ↗MalfunctionJul 21, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBE, THE SOLUTION WITHIN THE TUBE BACKFLOWED INTO THE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561211 ↗MalfunctionJul 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBE, THERE WAS ORANGE/BROWN FOREIGN MATTER INSIDE ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22383756 ↗MalfunctionJun 15, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED AFTER FREEZING PAXGENE® BLOOD RNA TUBE, CLOTTING WAS SEEN AT THE BOTTOM OF AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22208679 ↗MalfunctionJun 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBE, AN UNSPECIFIED NUMBER OF TUBES CRACKED IN THE FREEZER RESULTING IN BLOOD LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22186984 ↗MalfunctionJun 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBE, FINE IMPURITIES, THE SAME COLOR AS THE RUBBER STOPPER, WERE SEEN INSIDE OF AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22124110 ↗MalfunctionApr 24, 2025Break; Break
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBE, THE RUBBER STOPPER OF ONE (1) TUBE IS CRACKED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21906089 ↗MalfunctionApr 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING TRANSPORT OF PAXGENE® BLOOD RNA TUBE, THE CAPS OF AN UNSPECIFIED NUMBER OF TUBES POPPED OFF. IT IS UNCLEAR WHETHER SAMPLE WAS SPILLED AS A RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774838 ↗MalfunctionApr 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING TRANSPORT OF PAXGENE® BLOOD RNA TUBE, THE CAPS OF AN UNSPECIFIED NUMBER OF TUBES HAD POPPED OFF. IT IS UNCLEAR WHETHER SAMPLE WAS SPILLED AS A RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774837 ↗MalfunctionApr 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING TRANSPORT OF PAXGENE® BLOOD RNA TUBE, THE CAPS OF AN UNSPECIFIED NUMBER OF TUBES POPPED OFF. IT IS UNCLEAR WHETHER SAMPLE WAS SPILLED AS A RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21764024 ↗MalfunctionFeb 24, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING TRANSPORT OF PAXGENE® BLOOD RNA TUBE, THE CAPS OF 29 TUBES HAD POPPED OFF. IT IS UNCLEAR WHETHER SAMPLE WAS SPILLED AS A RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446906 ↗MalfunctionFeb 4, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBE, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21309600 ↗MalfunctionDec 11, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBES THAT TWO (2) TUBES CRACKED AND LEAKED AFTER A FREEZE THAW CYCLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20902098 ↗MalfunctionNov 14, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED BEFORE USING THE PAXGENE® BLOOD RNA TUBE THERE WAS A BLACK DOT FOREIGN MATTER INSIDE ONE DEVICE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20688073 ↗MalfunctionOct 25, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBES THAT ONE (1) TUBE BROKE DURING CENTRIFUGATION. THE TUBE WAS FROZEN AT -80 DEGREES CELSIUS AND LATER INCUBATED FOR APPROXIMATELY 2 HOURS BEFORE CENTRIFUGING AT 4200G FOR 10 MINUTES. THE SAMPLE WAS RECOLLECTED. THERE WAS NO FURTHER HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20530305 ↗MalfunctionOct 24, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED AFTER THAWING THE PAXGENE® BLOOD RNA TUBE, THERE WAS TUBE BREAKAGE AND SUBSEQUENT SAMPLE LEAKAGE ON EIGHT (8) DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20528119 ↗MalfunctionJul 25, 2024Short Fill; Short Fill
IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD RNA TUBE, THE TUBE UNDERFILLED DUE TO LOW VACUUM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19824452 ↗MalfunctionMay 24, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE TRANSPORTING FROZEN PAXGENE® BLOOD RNA TUBES THAT THE TUBES CRACKED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19395425 ↗MalfunctionApr 29, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD RNA TUBES, AFTER BEING REMOVED FROM THE FREEZER THE SAMPLES WERE LEAKING FROM THE CAPS. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19204439 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page