BD Vacutainer® Serum Blood Collection Tubes 366430Recalls & reported problems
Becton, Dickinson And Company · TUBE PLN GC 16X100 10.0 PLBL RD · Class 2
All models of BD Vacutainer Serum Blood Collection Tubes (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
These are BD Vacutainer serum blood collection tubes, used to draw and separate blood samples. The 50 reports mostly describe blood samples that clot too quickly or not at all, serum that fails to separate from red blood cells, underfilled or leaking tubes, and results that are hard to interpret — mostly leading to redraws rather than harm. No deaths or injuries were reported. One open recall from May 2022 covers tubes that had gotten too warm at a facility before delivery.
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
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 30382903664307), received between Dec 6, 2017 and Sep 9, 2026 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (13 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 25, 2022Class IIOpen, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1618-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings13
- Break7
- Component Missing5
- Device Ingredient or Reagent Problem5
- Coagulation in Device or Device Ingredient4
- Device Contamination with Chemical or Other Material3
- Device Operates Differently Than Expected3
- Leak/Splash3
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680899 ↗MalfunctionFeb 20, 2026Coagulation in Device or Device Ingredient
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 20 TUBES ALLOWED AIR INTO THE TUBE AND CLOTTING HAPPENED TOO QUICKLY RESULTING IN REDRAWS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405650 ↗MalfunctionFeb 11, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316485 ↗MalfunctionDec 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Improper Chemical Reaction; Incorrect, Inadequate or Imprecise Result or Readings; Improper Chemical Reaction
IT WAS REPORTED THAT CUSTOMER ALLEGES EXPERIENCING PERFORMANCE ISSUES WITH SERUM WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE CUSTOMER IS INQUIRING WHETHER SILICONE TUBES WOULD GENERATE MORE OR FEWER AGGREGATES IN THE SERUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796555 ↗MalfunctionSep 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES HAD NO SEPARATION AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077208 ↗MalfunctionSep 8, 2025Short Fill; Short Fill
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 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 22999301 ↗MalfunctionJun 5, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR SEPARATION, WHERE THE SERUM DID NOT SEPARATE FROM THE RED BLOOD CELLS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153580 ↗MalfunctionMay 28, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 100 TUBES DID NOT CLOT AS EXPECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22097764 ↗MalfunctionMay 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 1 TUBE THAT WAS USED AS A DISCARD TUBE WAS LEAKING AND WAS FOUND TO BE CRACKED AT THE TOP OF THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22006450 ↗MalfunctionApr 17, 2025Break; Break
IT WAS REPORTED DURING USE OF BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 3 TUBES BROKE IN THE CENTRIFUGE DURING PROCESSING. ONE OF THE 3 TUBES HAD A CHIP. AN UNSPECIFIED NUMBER OF TUBES HAD SCRATCHES AND WERE DISCARDED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21860424 ↗MalfunctionApr 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 7 TUBES HAD POOR SEPARATION BETWEEN SERUM AND RBC'S AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21748416 ↗MalfunctionFeb 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 3 SAMPLES EXHIBITED POOR SERUM. THE CUSTOMER INDICATED "WHEN LEACHING CHEMICALS, IT GIVES THE SUBSTANCE BUBBLES WHICH SHOULD NOT HAPPEN, THE PATIENT CANNOT USE THESE FOR CHEMICAL TESTING AS THEY ARE DEFECTIVE". THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411903 ↗MalfunctionJan 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AFTER USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THERE WAS FIBRIN PRESENT IN AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21102432 ↗MalfunctionDec 4, 2024Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844484 ↗MalfunctionNov 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED DURING USE OF BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, (B)(4) SAMPLES WERE NOT SEPARATING AFTER CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696534 ↗MalfunctionOct 17, 2024Break; Break
IT WAS REPORTED DURING USE OF BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 6 TUBES BROKE IN THE CENTRIFUGE DURING SAMPLE PROCESSING. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20478041 ↗MalfunctionAug 22, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES 1 TUBE WAS BROKEN AND LEAKED WHEN ATTEMPTING TO COLLECT A SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20031614 ↗MalfunctionJul 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES AN UNSPECIFIED NUMBER OF TUBES EXHIBIT POOR CLOT FORMATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19826370 ↗MalfunctionJun 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES 1 SAMPLE WAS NOT MIXING PROPERLY RESULTING IN POOR SERUM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19542195 ↗MalfunctionJun 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES AN UNSPECIFIED NUMBER OF TUBES WERE NOT CLOTTING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19493403 ↗MalfunctionJun 1, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES FIBRIN WAS NOTICED AFTER CENTRIFUGATION IN AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19443216 ↗MalfunctionMay 21, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® SERUM BLOOD COLLECTION TUBES ONE TUBE WAS FOUND WITH GLASS INSIDE. THE TUBE WAS INTACT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19365216 ↗MalfunctionMay 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES 5 SAMPLES WERE NOT SEPARATING CORRECTLY RESULTING IN POOR SERUM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19337119 ↗MalfunctionMay 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THE BLOOD WAS NOT CLOTTING FOR THREE TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19235698 ↗MalfunctionApr 2, 2024Component Missing; Component Missing
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES DID NOT CLOT PROPERLY. SAMPLE RECOLLECTION OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19021450 ↗
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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 · each recall links to the FDA recall notice
- 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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