BD Microtainer® Tubes w/ FE (Sodium Fluoride/Disodium EDTA) Glycolytic Inhibitor 365992Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30382903659921), received between May 16, 2018 and Sep 18, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (1 report).

1 FDA recall record name this device's identifier.

9 other recalls cover devices cleared under the same FDA submission (K002456); they may or may not involve this specific model.

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.

Recalls naming this device

1. May 13, 2019Class IITerminated

   Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

   Z-0061-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES W/ FE (SODIUM FLUORIDE/DISODIUM EDTA) GLYCOLYTIC INHIBITOR AN UNSPECIFIED NUMBER OF TUBES LOST THEIR CAP IN THE CENTRIFUGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251887 ↗
• MalfunctionApr 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD MICROTAINER® TUBES WITH FE (SODIUM FLUORIDE/DISODIUM EDTA), A TUBE WITH RAT BLOOD CLOTTED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166342 ↗
• MalfunctionApr 21, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® TUBES WITH FE (SODIUM FLUORIDE/DISODIUM EDTA), AN UNSPECIFIED AMOUNT OF TUBES WERE CLOTTING WHEN ANIMAL HEART BLOOD WAS COLLECTED VIA A SYRINGE AND THEN TRANSFERRED INTO THE MICROTAINER TUBES. THERE WAS NO IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19150129 ↗
• MalfunctionMay 17, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD MICROTAINER® TUBES WITH FE (SODIUM FLUORIDE/DISODIUM EDTA) WEREN¿T DRAWING A SUFFICIENT VOLUME OF BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7524054 ↗
• MalfunctionMay 16, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THE BD MICROTAINER® TUBES WITH FE (SODIUM FLUORIDE/DISODIUM EDTA) WERE CLOTTING, NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7519560 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002456. One submission often covers many models, so check the product and lot details in each record.

• Z-0054-2020 · May 13, 2019 · Terminated
  BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
• Z-0057-2020 · May 13, 2019 · Terminated
  BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
• Z-0056-2020 · May 13, 2019 · Terminated
  BD Microtainer SST Part/Catalog No.365967
• Z-0060-2020 · May 13, 2019 · Terminated
  BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
• Z-0059-2020 · May 13, 2019 · Terminated
  BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
• Z-0055-2020 · May 13, 2019 · Terminated
  BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
• Z-0058-2020 · May 13, 2019 · Terminated
  BD Microtainer SST- Amber Part/Catalog Number: 365978
• Z-0957-2007 · May 17, 2007 · Terminated
  BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ
• Z-1603-05 · Aug 20, 2004 · Terminated
  BD Vacutainer Microtainer Serum tubes (with or without gel).