BD Vacutainer® Urinalysis Preservative Urine Tube 365017Recalls & reported problems
Becton, Dickinson And Company · TUBE URIN PLH 16X100 8.0 UAP PLBL YEL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer urinalysis preservative urine tube is a sterile plastic specimen container used to collect and hold urine samples for lab testing. The 31 reports mostly describe test results reading incorrectly or inconsistently, plus tubes arriving underfilled, and one mention of contamination. No deaths and no injuries are reported, and all31 cases were filed as malfunctions with no patient symptoms noted. There are no recalls naming this device. Reports rose sharply, from 1 in the prior 12 months to 30 in the last 12.
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
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 30382903650171), received between Jun 4, 2025 and Sep 8, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (21 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings21
- Short Fill10
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680301 ↗MalfunctionAug 11, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202860 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086127 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient 10 of 21:It was reported during a validation study using BD Vacutainer® Urinalysis Preservative Urine Tube, 1 patient sample is not preserved over the 72 hours as indicated in Instruction for Use. There was no health impact or consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086126 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086124 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086123 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086122 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086121 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086120 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086118 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086117 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient (b)(6):It was reported during a validation study using BD Vacutainer® Urinalysis Preservative Urine Tube, 1 patient sample is not preserved over the 72 hours as indicated in Instruction for Use. There was no health impact or consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086116 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086115 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086112 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086111 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086110 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086109 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086108 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086107 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086106 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086105 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086103 ↗MalfunctionApr 17, 2026Short Fill
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® URINALYSIS PRESERVATIVE URINE TUBE, 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 24912266 ↗MalfunctionApr 16, 2026Short Fill
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® URINALYSIS PRESERVATIVE URINE TUBE, 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 24899346 ↗MalfunctionApr 16, 2026Short Fill
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® URINALYSIS PRESERVATIVE URINE TUBE, AN UNSPECIFIED NUMBER OF UNITS UNDERFILL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896211 ↗
Other CONTAINER, SPECIMEN, STERILE devices
- BD Vacutainer® Urine Analysis Preservative Tube 364992Becton, Dickinson And Company · CONTAINER, SPECIMEN, STERILE160 reports
- Medline Industries, Inc. DYNJ50241CMedline Industries, Inc. · CONTAINER, SPECIMEN, STERILE3 recalls0 reports
- BD Vacutainer® No Additive (Z) Tubes 366703Becton, Dickinson And Company · CONTAINER, SPECIMEN, STERILE143 reports
- Medline Industries, Inc. DYNJ63118AMedline Industries, Inc. · CONTAINER, SPECIMEN, STERILE2 recalls0 reports
- MyCareLink Smart™ 25000Medtronic, Inc. · CONTAINER, SPECIMEN, STERILE1 recall5 reports
- Centurion MG912STCenturion Medical Products Corporation · CONTAINER, SPECIMEN, STERILE1 recall0 reports
- Vacuette 450225Greiner Bio-One GmbH · CONTAINER, SPECIMEN, STERILE1 recall0 reports
- Medline Industries, Inc. DYNJ905664IMedline Industries, Inc. · CONTAINER, SPECIMEN, STERILE1 recall0 reports
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
- 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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