BD Vacutainer® Sodium Fluoride/Potassium Oxalate 15mg/12mg 367925Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 30382903679257), received between Dec 1, 2017 and Dec 15, 2025 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (9 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Improper Chemical Reaction; Improper Chemical Reaction

  REPORT 2 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 15MG/12MG, ONE (1) TUBE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811356 ↗
• MalfunctionDec 15, 2025Improper Chemical Reaction; Improper Chemical Reaction

  REPORT 3 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 15MG/12MG, ONE (1) TUBE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811355 ↗
• MalfunctionDec 15, 2025Improper Chemical Reaction; Improper Chemical Reaction

  REPORT 4 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 15MG/12MG, ONE (1) TUBE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811353 ↗
• MalfunctionDec 15, 2025Improper Chemical Reaction; Improper Chemical Reaction

  REPORT 1 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 15MG/12MG, ONE (1) TUBE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811350 ↗
• MalfunctionOct 23, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 15MG/12MG, THE CUSTOMER HAD CLOTTING ISSUES ON UNSPECIFIED NUMBER OF TUBES. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515263 ↗
• MalfunctionSep 3, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 15MG/12MG, AN UNSPECIFIED AMOUNT OF TUBE UNDERFILLED. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127278 ↗
• MalfunctionMar 1, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES THE SAMPLES WERE CLOTTING. THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822342 ↗
• MalfunctionJan 18, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED BY THE CUSTOMER THAT THE BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES ARE CLOTTING. THE SAMPLES HAD TO BE RECOLLECTED, BUT NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18539870 ↗
• MalfunctionNov 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING WITH BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES SAMPLES SHOWED HEMOLYSIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SAMPLES ARE HEMOLYZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097184 ↗
• MalfunctionOct 20, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES THERE WAS HEMOLYSIS. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: THE SAMPLES DRAWN IN THESE TUBES ARE HEMOLYZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975064 ↗
• MalfunctionOct 13, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES HEMOLYSIS OCCURS. SAMPLES WERE RECOLLECTED, ADDITIONAL PATIENT INFORMATION OR IMPACT HAS NOT BEEN REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED ABOUT 40-50% OF THEIR FLUORIDE TUBES HAVING HEMOLYSIS ISSUE AND CAUSING SPECIMEN RECOLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935943 ↗
• MalfunctionApr 26, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT AFTER USE WITH 4 BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES THE SAMPLES HAD CLOTTED. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS THE 2ND OF 4 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING THEY HAD FEW SAMPLES THAT WERE DRAWN WITHIN DAYS OF EACH OTHER THAT SEEM TO HAVE CLOTTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818163 ↗
• MalfunctionApr 26, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT AFTER USE WITH 4 BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES THE SAMPLES HAD CLOTTED. THERE WAS NO REPORTED PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING THEY HAD FEW SAMPLES THAT WERE DRAWN WITHIN DAYS OF EACH OTHER THAT SEEM TO HAVE CLOTTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818151 ↗
• MalfunctionApr 26, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT AFTER USE WITH 4 BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES THE SAMPLES HAD CLOTTED. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS THE 3RD OF 4 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING THEY HAD FEW SAMPLES THAT WERE DRAWN WITHIN DAYS OF EACH OTHER THAT SEEM TO HAVE CLOTTED FOR ITEM 367925, LOT# 2109102 AND 2132113.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818149 ↗
• MalfunctionApr 26, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT AFTER USE WITH 4 BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES THE SAMPLES HAD CLOTTED. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS THE 1ST OF (B)(4) OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING THEY HAD FEW SAMPLES THAT WERE DRAWN WITHIN DAYS OF EACH OTHER THAT SEEM TO HAVE CLOTTED FOR ITEM (B)(4), LOT# 2109102 AND 2132113.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818143 ↗
• MalfunctionJan 4, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES PRESENTED HEMOLYSIS. VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT HEMOLYSIS OCCURRED. CUSTOMER STATES SAMPLES ARE HEMOLYZED, SEVERAL LOTS SHOWED HEMOLYSIS. CUSTOMER DOES NOT HAVE INFORMATION ON LOTS AFFECTED OTHER THAN THE LOT GIVEN FOR THIS CASE. HEMOLYSIS OCCURS IF TUBE IS ADEQUALITY FILLED OR SHORT DRAW. TUBES VARY FROM FEW MINUTES TO 30 MINUTES BEFORE CENTRIFUGED. TUBES SPUN AT 3800RPM FOR 5 MIN. DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096137 ↗
• MalfunctionSep 23, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHEN USING THE BD TUBE GLU PLH 13X100 6.0 PLBL GR THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE RECEIVED PRODUCT LABELED AS 367925; HOWEVER, THE TUBES WERE ACTUALLY MATERIAL 367886.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15474165 ↗
• MalfunctionSep 23, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBE THERE WAS MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "TODAY, THE SUPPLY TEAM REPORTED THIS DEVIATION: IN A RACK OF GRAY CAP TUBES, POTASSIUM OXALATE / SODIUM FLUORIDE, 2 TUBES FROM ANOTHER BATCH WERE FOUND THAT WERE ALREADY EXPIRED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473337 ↗
• MalfunctionOct 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN TUBES FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TUBE WAS LABELED FOR THE DEVELOPMENT OF THE STUDY AND IN THE REVIEW FOR DELIVERY TO THE NURSING STAFF, HAIR WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682530 ↗
• MalfunctionOct 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE IS A HAIR INSIDE THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682416 ↗
• MalfunctionNov 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER CENTIFUGATION WITH BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES HEMOLOYSIS OCCURRED WITH 2 OF 10 TUBES DRAWN. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 2 TUBE HEMOLYZED AFTER CENTRIFUGE. HE IS USING THE TUBE FOR LACTIC ACID TESTING. HE STATED THAT HE DREW 10 TUBES FROM A PATIENT, AND 2 OF THEM WERE THE FLUORIDE TUBED, AND MENTINED THAT HE FOLLOWED THE PROPER ORDER OF DRAW, AND DID NOT SHAKE THE TUBES. THE 2 FLUORIDE TUBES HAD 2+ HEMOLYSIS, ACCORDING TO HIS HEMOLYSIS CHART. I EXPLAINED THAT THE OXALATE MAY CAUSE HEMOLYSIS, BUT THE 2 ML EDTA TUBE WAS NOT A GOOD OPTION FOR HIS TESTING. I EXPLAINED THAT WE HAD A WHITE PAPER EXPLAINING THAT THE OXALATE MAY CAUSES HEMOLYSIS, BUT THAT PAPER HAS BEEN OBSOLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10831473 ↗
• MalfunctionMar 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Overfill; Incorrect, Inadequate or Imprecise Result or Readings; Overfill

  IT WAS REPORTED THAT OVERFILL OCCURRED AFTER USE WITH A BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE TUBE OVERFILLED CAUSING THE STUDY TO BE CANCELLED. STUDY WAS CANCELLED AND PT HAS NOT RETURNED FOR REDRAW. CUSTOMER DOESN'T FEEL THE TUBE WAS OVER FILLED. IT WAS THE REFERENCE LAB WHICH REJECTED THE SPECIMEN BECAUSE TOO MUCH PLASMA WAS SUBMITTED. THEY ARE USED TO GETTING PLASMA SUBMITTED FROM THE 3-4 ML TUBES NOT THE 6 ML TUBE. PLASMA WAS SUBMITTED FOR LACTATE TESTING. SITE DID NOT HAVE LOT# OF TUBE. SPOKE ABOUT THERE BEING A NOMINAL FILL INDICATOR ON TUBE LABEL. SENT LABEL BROCHURE TO CUSTOMER TO SEE THE NOMINAL FILL LINE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9861401 ↗
• MalfunctionSep 13, 2019Incorrect, Inadequate or Imprecise Result or Readings; Device Contamination with Chemical or Other Material; Incorrect, Inadequate or Imprecise Result or Readings; Device Contamination with Chemical or Other Material

  MATERIAL NO: 367925 BATCH NO: UNKNOWN IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES THE SIDE OF THE TUBES APPEARED CLOUDY, POSSIBLY FROM THE POWER STICKING TO THE SIDE OF THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT THE TUBES APPEAR CLOUDY WHICH IS NOT NORMAL. "CUSTOMER STATES THAT SHE HAS NEVER SEEN THE TUBES LOOK LIKE THIS. BECAUSE ALL THE TUBES IN THEIR INVENTORY LOOKED THE SAME THEY WERE PASSED BY THE QC DEPARTMENT AND PUT INTO KITS. THE TUBES APPEAR TO HAVE A HEAVY FILM ON THE INSIDE AND SHE IS JUST INQUIRING IF THIS IS NORMAL BECAUSE SHE HAS NEVER SEEN THE TUBES LOOK LIKE THIS. CUSTOMER DID NOT CONSIDER THIS A COMPLAINT BUT EXPLAINED THAT ACCORDING TO OUR PROCESS IT WOULD FALL UNDER OUR COMPLAINT HANDLING PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9032723 ↗
• MalfunctionMay 9, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT 500 BD VACUTAINER® SODIUM FLUORIDE 15 MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES EXPERIENCED CLOTTING/MICRO CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367925, BATCH NO. 8156799. WE HAVE USED YOUR GRAY TOP TUBES FOR NUMEROUS STUDIES OVER MANY YEARS, BUT JUST RECENTLY HAVE EXPERIENCED CLOTTING ISSUES. THE LOT # IS 8156799 WITH AN EXPIRATION 2019-11-30.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8595292 ↗
• MalfunctionApr 16, 2019Coagulation in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings; Coagulation in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG(FX) COLLECTION TUBES WAS CLOTTING AND GIVING ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367925 BATCH NO. 8215742. **THE CUSTOMER WOULD LIKE TO KNOW WHAT THEY ARE DOING WRONG BECAUSE THEY ARE SEEING WHAT LOOKS LIKE COAGULATION AND PRECIPITATION ONCE THE PLASMA IS PULLED AND THE SAMPLE SITS. DOESN'T BELIEVE THAT IT'S AN ISSUE WITH THE PRODUCT** DURING THE VALIDATION OF THE GREY TOPS THE CUSTOMER IS SEEING WHAT LOOKS LIKE COAGULATION AND PRECIPITATION ONCE THE PLASMA IS PULLED AND DOES NOT SPIN DOWN WELL. IN THERE STUDY THEY HAVE NOTICED A NEGATIVE BIAS. AGILENT 7890 GAS CHROMATOGRAPH. DATE OF EVENT IS UNKNOWN. QUANTITY IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8518525 ↗