BD Vacutainer® Rapid Serum Tube (RST) Blood Collection Tubes Thrombin 368774Recalls & reported problems
Becton, Dickinson And Company · TUBE BD VACUTAINER RST 13X100 5.0ML · Class 2
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
This BD Vacutainer Rapid Serum Tube with thrombin is a blood collection tube. Its 257 reports mostly describe incorrect or unreliable test results, with some mentioning falsely high troponin readings and gel smearing on the tube side. There were no deaths and 2 injuries, and reports rose to 10 in the last 12 months from 1 in the 12 months before. One recall, open since May 2022, concerns tubes exposed to higher temperatures at a facility before delivery, which may have affected how well they work.
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
- 251
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 251 adverse event reports that list this exact device (DI 30382903687740), received between Apr 10, 2018 and Jan 21, 2026 — classified as 2 injuries, 249 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (211 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 Readings211
- Device Ingredient or Reagent Problem20
- Incorrect Or Inadequate Test Results9
- Leak/Splash5
- Coagulation in Device or Device Ingredient4
- Component Missing2
- Ambient Temperature Problem1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions207
- No Known Impact Or Consequence To Patient33
- No Consequences Or Impact To Patient8
- No Information4
Recent adverse event reports
The 25 most recent of 251 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2026Device Ingredient or Reagent Problem
REPORT 2 OF 2: IT WAS REPORTED DURING A STUDY USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN, 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 24138792 ↗MalfunctionJan 21, 2026Device Ingredient or Reagent Problem
REPORT 2 OF 2: IT WAS REPORTED DURING A STUDY USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN, 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 24138135 ↗MalfunctionJan 21, 2026Device Ingredient or Reagent Problem
REPORT 1 OF 2: IT WAS REPORTED DURING A STUDY USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN, 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 24138116 ↗MalfunctionJan 21, 2026Device Ingredient or Reagent Problem
REPORT 1 OF 2: IT WAS REPORTED DURING A STUDY USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN, 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 24138113 ↗MalfunctionFeb 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN, ERRONEOUS CRITICAL K RESULTS WERE SEEN 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 21378887 ↗MalfunctionOct 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING A BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN TO COLLECT BLOOD FROM CHEMO PATIENTS, THE BLOOD SAMPLES HAVE FIBRIN CLOTS IN THE SERUM. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20567328 ↗MalfunctionJun 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN THAT POOR BARRIER SEPARATION OF THE SERUM FROM CELLS OCCURRED IN TEN (10) TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19550382 ↗MalfunctionMay 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN THAT THE FULL SAMPLE TUBE WOULD HAVE GEL ON TOP OF THE SERUM ONCE IT CENTRIFUGED. NO IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19367104 ↗MalfunctionApr 10, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® RAPID SERUM TUBE (RST) THROMBIN, ONE TUBE HAD POOR SERUM SEPARATION AND RE-MIXED. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19080943 ↗MalfunctionApr 10, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® RAPID SERUM TUBE (RST) THROMBIN, THERE WAS AN UNSPUN PORTION OF THE SPECIMEN ONCE THE CENTRIFUGE HAD STOPPED AND THE FIBROUS CLOT HAD TO BE REMOVED AND THEN THE SPECIMEN WAS RESPUN. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19080234 ↗InjuryMar 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN, THE INITIAL SAMPLE PRODUCED ERRONEOUS RESULTS FOR TROPONIN I. THE PATIENT WAS TREATED BASED ON ERRONEOUS RESULTS, BUT THE ERRONEOUS TREATMENT DID NOT HAVE ANY ADVERSE IMPACT TO THE PATIENT. NO OTHER INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19003868 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18996466 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18995748 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18995709 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18995695 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18995552 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18995159 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18995025 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994745 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994528 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994489 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994218 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994206 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18993992 ↗MalfunctionMar 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18993945 ↗
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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.
How reports and recalls are matched · Editorial policy · Report an error on this page