BD Vacutainer® Serum 367820Recalls & reported problems
Becton, Dickinson And Company · Tube PLN PLC 16X100mm 10.0ml PLBL RD · Class 2
All models of BD Vacutainer Serum (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer serum blood collection tube is used to collect blood samples for serum tests. Its 148 reports describe tubes that are underfilled, have white flakes or residue inside, leak, or lose vacuum, and some mention inaccurate results. The reports include 2 injuries and no deaths. 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
- 148
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 30382903678205), received between Nov 29, 2017 and May 18, 2026 — classified as 2 injuries, 146 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (28 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings28
- Device Contamination with Chemical or Other Material26
- Short Fill25
- Leak/Splash17
- Incorrect Or Inadequate Test Results15
- Volume Accuracy Problem12
- Device Ingredient or Reagent Problem10
- Component Missing7
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- No Known Impact Or Consequence To Patient65
- No Consequences Or Impact To Patient9
- No Information5
- No Patient Involvement3
- Exposure to Body Fluids1
- Hemolysis1
Recent adverse event reports
The 25 most recent of 148 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, FOIUR TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25202360 ↗MalfunctionFeb 6, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, WHITE FLAKES AND RESIDUE ARE SEEN IN 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 24279202 ↗MalfunctionFeb 4, 2026Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, WHITE FLAKES AND RESIDUE ARE SEEN IN 1,336 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261891 ↗MalfunctionDec 18, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, ONE CASE OF TUBES ARE EXHIBITING DECREASED VACUUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839546 ↗MalfunctionDec 16, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, SIX TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816937 ↗MalfunctionDec 10, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23773539 ↗MalfunctionOct 28, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® SERUM, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED TEMPERATURE EXCURSION DURING TRANSPORT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408422 ↗MalfunctionJul 11, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, 20 TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22485398 ↗MalfunctionJul 7, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THE ADDITIVE IN 15 TUBES APPEARS TO BE CLUMPING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22414528 ↗MalfunctionJun 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, AN UNSPECIFIED NUMBER OF TUBES ARE NOT CLOTTING AFTER COLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22195576 ↗MalfunctionMay 22, 2025Component Missing; Component Missing
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, 15 SAMPLES CLOTTED POST CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069833 ↗MalfunctionApr 21, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THE LOT NUMBER AND EXPIRATION DATE WERE MISSING FROM 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 21876773 ↗MalfunctionFeb 5, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THERE WAS POOR BARRIER SEPARATION SEEN IN 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 21313751 ↗MalfunctionDec 13, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SERUM TUBES WERE USED PAST THEIR EXPIRATION DATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20930750 ↗MalfunctionDec 3, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM THERE WAS SAMPLE LEAKAGE THROUGH THE CAP ON AN UNSPECIFIED NUMBER OF DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20831394 ↗MalfunctionOct 28, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED BEFORE USING THE BD VACUTAINER® SERUM, THERE WAS WHITE FOREIGN MATTER IN TWO (2) DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20545797 ↗MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT ONE HUNDRED (100) TUBES HAD AN ABNORMAL ADDITIVE APPEARANCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950361 ↗MalfunctionJun 28, 2024Component Missing; Component Missing
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM TUBE, THE TUBE DID NOT CLOT LEADING TO THE SAMPLE NOT BEING ABLE TO BE USED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639105 ↗MalfunctionApr 25, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WERE RED BLOOD CELLS IN THE SERUM AFTER CENTRIFUGATION RESULTING IN POOR SERUM; INADEQUATE SEPARATION OF THE SAMPLE. THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181914 ↗MalfunctionApr 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WERE RED BLOOD CELLS IN THE SERUM AFTER CENTRIFUGATION RESULTING IN POOR SERUM; INADEQUATE SEPARATION OF THE SAMPLE. THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181652 ↗MalfunctionApr 25, 2024Short Fill; Short Fill
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM 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 19181508 ↗MalfunctionApr 24, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WERE RED BLOOD CELLS IN THE SERUM AFTER CENTRIFUGATION RESULTING IN POOR SERUM; INADEQUATE SEPARATION OF THE SAMPLE. THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19177809 ↗MalfunctionApr 24, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WERE RED BLOOD CELLS IN THE SERUM AFTER CENTRIFUGATION RESULTING IN POOR SERUM; INADEQUATE SEPARATION OF THE SAMPLE. THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19177080 ↗MalfunctionApr 10, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WERE RED BLOOD CELLS IN THE SERUM AFTER CENTRIFUGATION RESULTING IN POOR SERUM; INADEQUATE SEPARATION OF THE SAMPLE. THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19079011 ↗MalfunctionDec 14, 2023Component Missing; Component Missing
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAD MISSING STOPPERS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18329067 ↗
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- BD Vacutainer® SST™ 367983Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls1,075 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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