BD Vacutainer® Sodium Fluoride/Potassium Oxalate 10mg/8mg 367922Recalls & reported problems
Becton, Dickinson And Company · TUBE GLU PLH 13X75 4.0 PLBL GR · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer blood collection tube is used to collect blood for glucose testing. Its 155 reports mostly describe blood clotting inside the tube, and some describe tubes that were underfilled or whose blood cells broke open. The reports include no deaths and no injuries. No recalls name this device. Reports rose from 2 in the year before to 8 in the latest year.
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
- 155
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 30382903679226), received between Mar 5, 2018 and Jul 27, 2026 — classified as 155 malfunctions.
The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (92 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
- Coagulation in Device or Device Ingredient92
- Short Fill14
- Incorrect, Inadequate or Imprecise Result or Readings13
- Device Ingredient or Reagent Problem10
- Device Markings/Labelling Problem7
- Improper Chemical Reaction7
- Component Missing5
- Volume Accuracy Problem4
Patient problems
- No Known Impact Or Consequence To Patient86
- No Clinical Signs, Symptoms or Conditions50
- No Consequences Or Impact To Patient11
- No Information4
- Hemolysis2
- No Patient Involvement1
- Thrombus1
Recent adverse event reports
The 25 most recent of 155 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Improper Chemical Reaction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50045787 ↗MalfunctionJul 27, 2026Improper Chemical Reaction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50045785 ↗MalfunctionMay 13, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 10MG/8MG, 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 25163526 ↗MalfunctionDec 16, 2025Improper Chemical Reaction; Improper Chemical Reaction
REPORT 4 OF 5: IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 10MG/8MG, ONE (1) TUBE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824768 ↗MalfunctionDec 16, 2025Improper Chemical Reaction; Improper Chemical Reaction
REPORT 5 OF 5: IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 10MG/8MG, ONE (1) TUBE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824766 ↗MalfunctionDec 16, 2025Improper Chemical Reaction; Improper Chemical Reaction
REPORT 2 OF 5: IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 10MG/8MG, ONE (1) TUBE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824763 ↗MalfunctionDec 16, 2025Improper Chemical Reaction; Improper Chemical Reaction
REPORT 3 OF 5: IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 10MG/8MG, ONE (1) TUBE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824759 ↗MalfunctionDec 15, 2025Improper Chemical Reaction; Improper Chemical Reaction
REPORT 1 OF 5: IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 10MG/8MG, ONE (1) TUBE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23811693 ↗MalfunctionJun 2, 2025Short Fill; Short Fill
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM, THE TUBES UNDERFILLED ON UNSPECIFIED NUMBER OF TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22125952 ↗MalfunctionJun 2, 2025Short Fill; Short Fill
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM, THE TUBES UNDERFILLED ON UNSPECIFIED NUMBER OF TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22125771 ↗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 10MG/8MG BLOOD COLLECTION TUBES, 14 TUBES CLOTTED. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20515483 ↗MalfunctionOct 17, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 10MG/8MG BLOOD COLLECTION TUBES, TWENTY (20) TUBES HEMOLYZED. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20477204 ↗MalfunctionOct 15, 2024Component Missing; Component Missing
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 10MG/8MG, THE CUSTOMER NOTICED ONE (1) TUBE WAS MISSING THE MIXTURE. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20454158 ↗MalfunctionSep 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES THAT THIRTEEN (13) TUBES HAD ADDITIVE THAT WAS NOT DISTRIBUTED EVENLY AND ABNORMALLY WHITE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20181191 ↗MalfunctionMar 15, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBES, (B)(4) TUBES FLEW OFF THE HUB (TUBE PUSH-OFF). THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18917418 ↗MalfunctionMar 13, 2024Short Fill; Short Fill
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBES, THE TUBES WERE UNDERFILLING. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18897538 ↗MalfunctionMar 13, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBES, THE SAMPLES WERE CLOTTED. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895262 ↗MalfunctionFeb 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES, ONE PATIENT HAD DISCREPANT LACTIC ACID RESULTS. THE PATIENT'S SAMPLE WAS RECOLLECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THE SPECIMEN WAS INITIALLY DRAWN FROM THE TOP OF THE HAND USING A WING-SET COLLECTION SET. THE PATIENT WAS A DIALYSIS PATIENT. THE INITIAL RESULT WAS 5.3. THE SAMPLE WAS RE-COLLECTED FROM THE PATIENT THE SAME DAY AND RE-RUN (WITHIN 1-2 HOURS AFTER FIRST SAMPLE) AND THE LACTIC ACID RESULT WAS 1.45.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18789669 ↗MalfunctionFeb 23, 2024Short Fill; Short Fill
IT WAS REPORTED THAT WHEN USING BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES THE TUBES ARE UNDERFILLING. RECOLLECTIONS WERE REQUIRED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18770700 ↗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 POTASSIUM OXALATE BLOOD COLLECTION TUBES ARE CLOTTING. THE SAMPLES WERE RECOLLECTED, AND THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18538300 ↗MalfunctionNov 30, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT THE SAMPLE PROBE CRASHED INTO RUBBER STOPPER ON BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBES, CAUSING THE INSTRUMENT TO STOP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18235984 ↗MalfunctionNov 27, 2023Short Fill; Short Fill
IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBE HAS BEEN FOUND UNDERFILLING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THEIR TUBES ARE DRAWING 3 ML INSTEAD OF 4, AND ARE INQUIRING IF THIS IS NORMAL SINCE THEY JUST STARTED USING THESE TUBES
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18212118 ↗MalfunctionOct 20, 2023Short Fill; Short Fill
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBES HAD UNDERFILLING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT UNDERFILLING WITH TUBES. AFFECTED LOT NUMBER 2166075.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17981522 ↗MalfunctionAug 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES THERE WERE LOW GLUCOSE LEVELS. PATIENT INFORMATION AND INCIDENT DETAILS WERE UNABLE TO BE OBTAINED. THIS OCCURRED ON AT LEAST 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS A CONSTANT OF DISCREPANT RESULTS ON GLUCOSE LEVELS REPORTING AS "CRITICALLY LOW". CUSTOMER REPORTS AT LEAST 3 INCIDENTS THIS WEEK, BUT MENTIONS IN THE PAST THIS HAS ALSO OCCURRED. ISSUE WAS ISOLATE TO TUBES FROM LOT#: 2200163.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17580744 ↗MalfunctionJul 31, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES THAT THERE WAS DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVE THE ISSUE PRESENTED ON DIFFERENT LOT NUMBERS? ALL PAST DELIVERIES CONTAINED THE WHITE POWDER INSIDE THE TUBE, BUT NOT SOLIDIFIED. HAVE THESE TUBE BEEN USED TO DRAW BLOOD FROM PATIENTS? NO HOW ARE THE TUBES BEING STORED? INSIDE THE BOXES SENT BY THE DISTRIBUTOR IN OUR TEMPERATURE CONTROLLED WAREHOUSE (15 - 25 C). HAS THE ISSUE PRESENTED ON EVERY TUBE FROM THE LOT? YES CUSTOMER IS CONCERN IN REGARDS TO THE ADDITIVE APPEARANCE ON LOT#: 3074286. THE POWDER SEEMS TO BE CLUMPING. "THE WHITE POWDER INSIDE OF MOST THE VACUTAINER TUBES SEEMS TO BE SOLIDIFIED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17431315 ↗
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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 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.
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