BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate 362760Recalls & reported problems
Becton, Dickinson And Company · TUBE CPTCIT GC 13X100 4.0 MLBL BL/BLK · Class 1
Quick summary
This BD Vacutainer CPT cell preparation tube is a laboratory tube used to separate blood cells before testing. Of its 129 reports, 128 are malfunctions and 1 is an injury, with no deaths; many describe incorrect results, and others describe poor separation of the layers, short fills or clumped cells. Reports fell to 4 in the last 12 months from 12 in the 12 months before. 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
- 129
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 30382903627609), received between Oct 27, 2017 and Jul 29, 2026 — classified as 1 injury, 128 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (55 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 Readings55
- Device Ingredient or Reagent Problem20
- Short Fill17
- Incorrect Or Inadequate Test Results11
- Device Contamination with Chemical or Other Material9
- Volume Accuracy Problem9
- Leak/Splash6
- Break5
Patient problems
- No Known Impact Or Consequence To Patient62
- No Clinical Signs, Symptoms or Conditions54
- No Consequences Or Impact To Patient6
- No Information6
- No Code Available1
Recent adverse event reports
The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072928 ↗MalfunctionFeb 19, 2026Device Ingredient or Reagent Problem
IT WAS REPORTED AFTER USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 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 24396940 ↗MalfunctionJan 21, 2026Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 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 24139369 ↗MalfunctionNov 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED A STRING-LIKE MATTER IN THE LIQUID DENSITY MEDIA (LDM). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23599666 ↗MalfunctionOct 22, 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 CITRATE, 1 SAMPLE EXHIBITED POOR BARRIER CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23359175 ↗MalfunctionOct 22, 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 CITRATE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR BARRIER CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358999 ↗MalfunctionSep 11, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED AFTER USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, THERE WAS POOR BARRIER SEPARATION SEEN IN THIRTY (30) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23027404 ↗MalfunctionJul 29, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBIT CLUMPED/STICKY MONONUCLEAR CELLS AFTER TOP LAYER IS REMOVED FROM TUBES AND PLACED IN A CONICAL TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22649029 ↗MalfunctionJul 24, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 5 SAMPLES EXHIBITED POOR SEPARATION AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588775 ↗MalfunctionJul 10, 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 CITRATE, 10 SAMPLES EXHIBITED EITHER POOR BARRIER SEPARATION AFTER PROCESSING OR LOW YIELD. CUSTOMER WAS UNABLE TO DETERMINE THE SPECIFIC OCCURRENCE FOR EACH ISSUE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22470649 ↗MalfunctionApr 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 2 TUBES EXHIBITED POOR BARRIER SEPARATION. AFTER RE-SPINNING BOTH TUBES, 1 STILL EXHIBITED POOR BARRIER SEPARATION(3 OCCURRENCES). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762920 ↗MalfunctionMar 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF SAMPLES HAD AN INSUFFICIENT CELLULAR PELLET AFTER THE 2ND WASH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21690056 ↗MalfunctionMar 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21689785 ↗MalfunctionMar 19, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 4 SAMPLES WERE CLOTTED RESULTING IN POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21648188 ↗MalfunctionMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBIT POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21596937 ↗MalfunctionJan 21, 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 CITRATE 110 TUBES CONTAINED FOREIGN MATTER(FM). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200374 ↗MalfunctionApr 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, THERE WAS POOR BARRIER SEPARATION OF A PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 2 OF 2
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049320 ↗MalfunctionApr 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, THERE WAS POOR BARRIER SEPARATION OF A PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049308 ↗MalfunctionMar 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, THERE WAS POOR BARRIER SEPARATION OF THE SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18818530 ↗MalfunctionFeb 21, 2024Crack; Missing Information; Crack; Missing Information
IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, THE USER OBSERVED THAT AN UNKNOWN NUMBER OF TUBE(S) WERE CRACKED, AND THE LABEL PRINT WAS ILLEGIBLE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18751199 ↗MalfunctionFeb 20, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, THERE WAS POOR BARRIER SEPARATION OF THE SAMPLE. SAMPLE WAS RECOLLECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18743679 ↗MalfunctionJan 10, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE A STOPPER DEFORMATION WAS FOUND BY THE USER. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18485940 ↗MalfunctionJan 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE FOREIGN MATTER WAS FOUND WITHIN THE TUBE PRIOR TO USE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18485938 ↗MalfunctionDec 7, 2023Short Fill; Short Fill
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE TUBES, THE TUBES PROVIDE A POOR RETURN OF BLOOD DURING BLOOD COLLECTION. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18283944 ↗MalfunctionOct 23, 2023Short Fill; Short Fill
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THAT THERE WAS UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD IN 15 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOW FILL VOLUME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17991307 ↗
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 Heparin 362753Becton, Dickinson And Company · LYMPHOCYTE SEPARATION MEDIUM271 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.