BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate 362761Recalls & reported problems
Becton, Dickinson And Company · TUBE CPTCIT GC 16X125 8.0 MLBL BL/BLK · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Vacutainer CPT is a blood collection tube used to separate blood cells for lab tests. Many of its 286 reports describe underfilled tubes, poor separation of the blood layers and inaccurate test results. The reports include no deaths and no injuries. One open recall began in May 2022 and concerns tubes exposed to higher temperatures before delivery, which may have reduced their effectiveness. Reports fell from 27 in the previous 12 months to 7 in the latest 12 months.
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
- 286
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 30382903627616), received between Oct 17, 2017 and Jul 27, 2026 — classified as 286 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (75 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 25, 2022Open, 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 · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings75
- Incorrect Or Inadequate Test Results61
- Short Fill43
- Break39
- Device Contamination with Chemical or Other Material22
- Device Ingredient or Reagent Problem21
- Volume Accuracy Problem19
- Leak/Splash14
Patient problems
- No Known Impact Or Consequence To Patient125
- No Clinical Signs, Symptoms or Conditions120
- No Consequences Or Impact To Patient25
- No Information13
- No Patient Involvement3
- Exposure to Body Fluids1
Recent adverse event reports
The 25 most recent of 286 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Short Fill; Improper Chemical Reaction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50020589 ↗MalfunctionApr 22, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954300 ↗MalfunctionFeb 2, 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 AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24239969 ↗MalfunctionJan 30, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, ONE (1) OF TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228424 ↗MalfunctionDec 17, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF TUBES HAD VACUUM LOSS RESULTING IN UNDERFILLED TUBES. THE TUBES WERE REPLACED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835405 ↗MalfunctionDec 3, 2025Device Ingredient or Reagent Problem; Device 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 (BLOOD IS NOT PASSING THROUGH FICOLL LAYER). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23711545 ↗MalfunctionNov 20, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT 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 23609558 ↗MalfunctionOct 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USE OF 21 CASES OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, THE OUTER CASE HAD AN INCORRECT EXPIRATION DATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357688 ↗MalfunctionOct 16, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23311101 ↗MalfunctionJul 9, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 5 SAMPLES EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22462505 ↗MalfunctionJun 23, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 3 SAMPLES EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22311096 ↗MalfunctionJun 20, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 3 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 22297370 ↗MalfunctionJun 9, 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, EXCESS RED BLOOD CELLS IN GEL WAS OBSERVED IN ONE MATERNAL SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22171447 ↗MalfunctionJun 9, 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, POOR BARRIER SEPARATION WAS SEEN IN ONE FETAL SAMPLE. THE SAMPLE WAS CENTRIFUGED FURTHER FOR AN ADDITIONAL 10 MINUTES (PER INSTRUCTION FOR USE) WITH THE SAME OUTCOME (POOR BARRIER SEPARATION). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22171429 ↗MalfunctionApr 30, 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 AND THE GEL CONSISTENCY WAS NOT ALWAYS FIRM (COULD BE GOOEY OR STRINGY). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936959 ↗MalfunctionApr 25, 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, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED CLUMPING DURING THE CELL WASHING/RESUSPENSION PHASE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908418 ↗MalfunctionApr 23, 2025Short Fill; Short Fill
IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 10 TUBES WERE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21893135 ↗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 IN A CLINICAL TRIAL, 1 PATIENT SAMPLE EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. PATIENT WAS RECOLLECTED AND AGAIN EXHIBITED POOR BARRIER SEPARATION. STUDY PARTICIPANT WAS REMOVED FROM TRIAL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21766803 ↗MalfunctionApr 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE IN A CLINICAL TRIAL, 1 PATIENT 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 21766227 ↗MalfunctionApr 2, 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,1 SAMPLE EXHIBITED CLUMPING DURING THE CELL WASHING/RESUSPENSION PHASE POST-CENTRIFUGATION. CELLS ARE NOT CLUMPED INITIALLY UPON HARVESTING; CLUMPING APPEARS DURING THE WASH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21753739 ↗MalfunctionMar 28, 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, 1 SAMPLE CONTAINED OIL GEL GLOBULES AFTER CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21723970 ↗MalfunctionMar 27, 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, 1 SAMPLE CONTAINED OIL GEL GLOBULES AFTER CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708478 ↗MalfunctionMar 19, 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, 4 SAMPLES EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21644423 ↗MalfunctionMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE ,1 PATIENT SAMPLE EXHIBITED POOR BARRIER SEPARATION. 2 SAMPLES WERE COLLECTED ON THE PATIENT DURING THE SAME COLLECTION, AND AFTER PROCESSING ONLY ONE SAMPLE EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21595029 ↗MalfunctionMar 12, 2025Break; Break
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 1 TUBE BROKE IN THE CENTRIFUGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21588807 ↗
Other LYMPHOCYTE SEPARATION MEDIUM devices
- BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Heparin 362753Becton, Dickinson And Company · LYMPHOCYTE SEPARATION MEDIUM271 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.