BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Heparin 362753Recalls & reported problems
Becton, Dickinson And Company · TUBE CPTHEP GC 16X125 8.0 MLBL RD/GN · Class 1
Quick summary
This BD Vacutainer CPT cell preparation tube, used to separate blood cells, has 269 reports, with no deaths and 12 injuries. Many describe inaccurate results, and some describe tubes breaking in the centrifuge, layers not separating properly, or underfilling. 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
- 271
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 271 adverse event reports that list this exact device (DI 30382903627531), received between Nov 27, 2017 and Sep 30, 2026 — classified as 12 injuries, 259 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (116 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings116
- Incorrect Or Inadequate Test Results38
- Device Ingredient or Reagent Problem37
- Break35
- Device Contamination with Chemical or Other Material12
- Short Fill12
- Coagulation in Device or Device Ingredient7
- Leak/Splash7
Patient problems
- No Clinical Signs, Symptoms or Conditions117
- No Known Impact Or Consequence To Patient113
- No Consequences Or Impact To Patient30
- No Information8
- No Code Available3
- Injury1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 271 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951843 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575097 ↗MalfunctionMay 5, 2026Fluid/Blood Leak
IT WAS REPORTED AFTER USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, ONE (1) TUBE BROKE INSIDE THE CENTRIFUGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086643 ↗MalfunctionApr 22, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, AN UNSPECIFIED NUMBER OF TUBES BROKE WITHIN THE CENTRIFUGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24959814 ↗MalfunctionFeb 9, 2026Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, POOR BARRIER SEPARATION WAS SEEN WITH TWO TUBES FROM ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298532 ↗MalfunctionJan 30, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228666 ↗MalfunctionJan 13, 2026Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058624 ↗MalfunctionJan 6, 2026Device Ingredient or Reagent Problem
IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23985531 ↗MalfunctionDec 19, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23854369 ↗MalfunctionDec 17, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, AN UNSPECIFIED NUMBER OF TUBES HAD VACUUM LOSS RESULTING IN UNDERFILLED TUBES. THE TUBE WAS REPLACED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835446 ↗MalfunctionDec 16, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 2 TUBES EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821476 ↗MalfunctionDec 8, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 6 TUBES EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746980 ↗MalfunctionDec 4, 2025Break; Break
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, ONE TUBE WAS FOUND BROKEN DURING CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23722217 ↗MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHILE CENTRIFUGING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 3 TUBES BROKE INSIDE THE CENTRIFUGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688421 ↗MalfunctionNov 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, ONE TUBE HAD A DEFECTIVE CAP MOLDING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23589610 ↗MalfunctionNov 13, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 3 TUBES FROM THE SAME PATIENT EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23547108 ↗MalfunctionNov 13, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 3 TUBES FROM THE SAME PATIENT EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23547104 ↗MalfunctionNov 11, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN THERE WAS A DEFECTIVE CAP MOLDING OBSERVED. AFTER USE, ONE CPT BLOOD COLLECTION TUBE (LOT: 5069090) CUSTOMER FOUND TO HAVE A LARGE, CHIPPED RUBBER STOPPER. IT IS ASSUMED THAT THE CHIP WAS THERE FROM THE BEGINNING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23527361 ↗MalfunctionNov 6, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 1 SAMPLE EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23493258 ↗MalfunctionOct 22, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356911 ↗MalfunctionSep 17, 2025Fracture; Fracture
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 1 TUBE WAS CRACKED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076281 ↗MalfunctionSep 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 2 TUBES CONTAINED FOREIGN MATTER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076042 ↗MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN DURING A STUDY, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION(INCLUDING EXCESSIVE RBC'S IN AND ON TOP OF THE GEL), GEL SMEARING(OFTEN CONTAINING RBC CONTAMINANTS), AND LOW YIELD AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23068889 ↗MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN DURING A STUDY, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION (INCLUDING EXCESSIVE RBC'S IN AND ON TOP OF THE GEL), GEL SMEARING (OFTEN CONTAINING RBC CONTAMINANTS), AND LOW YIELD AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23068248 ↗MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN DURING A STUDY, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION(INCLUDING EXCESSIVE RBC'S IN AND ON TOP OF THE GEL), GEL SMEARING(OFTEN CONTAINING RBC CONTAMINANTS), AND LOW YIELD AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23068225 ↗
Other LYMPHOCYTE SEPARATION MEDIUM devices
- BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate 362761Becton, Dickinson And Company · LYMPHOCYTE SEPARATION MEDIUM1 recall286 reports
- BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate 362760Becton, Dickinson And Company · LYMPHOCYTE SEPARATION MEDIUM129 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.