BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units 367962Recalls & reported problems

Summary

The FDA's MAUDE database contains 693 adverse event reports that list this exact device (DI 30382903679622), received between Oct 18, 2017 and Sep 30, 2026 — classified as 6 injuries, 687 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (267 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 12, 2019Class IITerminated

   False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

   Z-2303-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 693 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951849 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915151 ↗
• MalfunctionJun 23, 2026Material Deformation

  IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, A PIECE OF PLASTIC WAS OBSERVED PROTRUDING FROM THE GATE ON THE HEMOGARD CLOSURE 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 25598900 ↗
• MalfunctionJun 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, ERRONEOUS ELEVATED TROPONIN RESULTS WERE REPORTED ON ONE PATIENT. THE SECOND SAMPLE IN THE SERIES WAS NORMAL. ADDITIONALLY, AFTER RE-CENTRIFUGING THE ORIGINAL SAMPLE, NORMAL RESULTS WERE OBTAINED. FIBRIN AND POOR BARRIER SEPARATION WERE ALSO REPORTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549044 ↗
• MalfunctionJun 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, ERRONEOUS ELEVATED TROPONIN RESULTS WERE REPORTED ON ONE PATIENT. THE SECOND SAMPLE IN THE SERIES WAS NORMAL. ADDITIONALLY, AFTER RE-CENTRIFUGING THE ORIGINAL SAMPLE, NORMAL RESULTS WERE OBTAINED. FIBRIN AND POOR BARRIER SEPARATION WERE ALSO REPORTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549043 ↗
• MalfunctionMay 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, ELEVATED AST LEVELS WERE RECEIVED FOR 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 25086646 ↗
• MalfunctionApr 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, ERRONEOUS RESULTS WERE SEEN WITH AN UNSPECIFIED NUMBER OF TUBES AFTER PATIENTS WERE INJECTED WITH DYE USED FOR CT SCANS. RECOLLECTION OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25051147 ↗
• MalfunctionApr 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, ERRONEOUS RESULTS WERE SEEN WITH AN UNSPECIFIED NUMBER OF TUBES AFTER PATIENTS WERE INJECTED WITH DYE USED FOR CT SCANS. RECOLLECTION OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25051109 ↗
• MalfunctionApr 23, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED AFTER USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 83 UNITS, EIGHT (8) SAMPLES EXHIBITED CLOTTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972859 ↗
• MalfunctionApr 20, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBES, THE FILL VOLUME OF AN UNSPECIFIED NUMBER OF TUBES WAS NEAR ZERO. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924806 ↗
• MalfunctionApr 17, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, 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 24912796 ↗
• MalfunctionApr 16, 2026Separation Problem

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, THE STOPPER POPS OFF OF AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905331 ↗
• MalfunctionApr 8, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 83 UNITS BLOOD COLLECTION TUBES, THERE TWO (2) TUBES WITH POOR SEPARATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818524 ↗
• MalfunctionApr 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 6 OF 6: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 83 UNITS, ERRONEOUS RESULTS- POTASSIUM WERE SEEN IN ONE (1) SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777036 ↗
• MalfunctionApr 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 5 OF 6: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 83 UNITS, ERRONEOUS RESULTS- POTASSIUM WERE SEEN IN ONE (1) SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772186 ↗
• MalfunctionApr 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 3 OF 6: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 83 UNITS, ERRONEOUS RESULTS- POTASSIUM WERE SEEN IN ONE (1) SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772182 ↗
• MalfunctionApr 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 4 OF 6: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 83 UNITS, ERRONEOUS RESULTS- POTASSIUM WERE SEEN IN ONE (1) SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772175 ↗
• MalfunctionApr 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 2 OF 6: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 83 UNITS, ERRONEOUS RESULTS- POTASSIUM WERE SEEN IN ONE (1) SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772174 ↗
• MalfunctionApr 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 1 OF 6: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 83 UNITS, ERRONEOUS RESULTS- POTASSIUM WERE SEEN IN ONE (1) SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772173 ↗
• MalfunctionMar 17, 2026Separation Problem

  IT WAS REPORTED AFTER USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, THE STOPPER POPPED OFF ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624078 ↗
• MalfunctionFeb 24, 2026Separation Problem

  IT WAS REPORTED WHILE ATTEMPTING TO PULL BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, OUT OF THE HOLDER, THE STOPPER GOT STUCK AND SEPARATED FROM IT'S TUBE BODY. THIS OCCURRED WITH ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435603 ↗
• MalfunctionFeb 18, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, AN UNSPECIFIED NUMBER OF TUBES CONTAINED GEL AIR BUBBLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383896 ↗
• MalfunctionFeb 18, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED PRIOR TO AND DURING USE OF BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, 10 TUBES EXHIBITED BUBBLES IN THE GEL SEPARATION BARRIER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378124 ↗
• MalfunctionFeb 17, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED PRIOR TO AND DURING USE OF THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, THERE WERE BUBBLES IN THE GEL SEPARATION BARRIER OF 50 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373052 ↗
• MalfunctionFeb 11, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED BEFORE AND DURING USE OF BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, 15 TUBES EXHIBITED GEL AIR BUBBLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314041 ↗