BD Microtainer® Z (No Additive Tubes) 365963Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 30382903659631), received between May 4, 2018 and Jan 29, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (4 reports).

1 FDA recall record name this device's identifier.

8 other recalls cover devices cleared under the same FDA submission (K991702); 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-0054-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHEN USING THE BD MICROTAINER® Z (NO ADDITIVE TUBES), FOR AN UNSPECIFIED NUMBER OF UNITS, THERE WAS A WHITE MATERIAL IN THE TUBE AND BLOOD DID NOT SEPARATE WHEN THE TUBES WERE SPUN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210453 ↗
• MalfunctionJan 27, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD MICROTAINER® Z (NO ADDITIVE TUBES), AN UNSPECIFIED NUMBER OF TUBES EXHIBITED ADDITIVE ABNORMALITY PRESENTING AS WHITE MATERIAL. ADDITIONALLY, THE BLOOD OF AN UNSPECIFIED NUMBER OF TUBES DID NOT SEPARATE WHEN SPUN, IT TURNED BROWN AND GRANULAR. RECOLLECTION WAS NECESSARY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192743 ↗
• MalfunctionJan 9, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD MICROTAINER® Z (NO ADDITIVE TUBES), AN UNSPECIFIED NUMBER OF TUBES EXHIBITED ADDITIVE ABNORMALITY PRESENTING AS WHITE MATERIAL. ADDITIONALLY, THE BLOOD OF AN UNSPECIFIED NUMBER OF TUBES DID NOT SEPARATE WHEN SPUN, IT TURNED BROWN AND GRANULAR. RECOLLECTION WAS NECESSARY. FIVE TUBES WERE AFFECTED; HOWEVER, IT WAS UNSPECIFIED WHICH SAMPLE PRESENTED WHICH DEFECT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027701 ↗
• MalfunctionMar 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE OF BD MICROTAINER® Z (NO ADDITIVE TUBES), 4 TUBES CONTAINED FIBRIN CLOTS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521683 ↗
• MalfunctionSep 18, 2024Fluid/Blood Leak; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD MICROTAINER® Z (NO ADDITIVE TUBES) 10 SAMPLES HAD POOR SERUM(NOT SEPARATED PROPERLY), FIBRIN, AND CAPS OPENED IN THE CENTRIFUGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250269 ↗
• MalfunctionJan 13, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® Z THERE WAS POOR BARRIER SEPARATION OF THE SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE SAMPLE IS NOT SPINNING PROPERLY DURING CENTRIFUGATION AND HAS TO BE SPIN MULTIPLE TIMES IN ORDER FOR THE SAMPLE TO SEPARATE PROPERLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162213 ↗
• MalfunctionSep 21, 2021Component Missing; Component Missing

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® Z (NO ADDITIVE TUBES) THERE WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN CENTRIFUGING THE MICROTAINERS, THERE IS NO SERUM SEPARATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507161 ↗
• MalfunctionFeb 11, 2021Component Missing; Component Missing

  IT WAS REPORTED WHEN USING THE TUBE MICRO W/MICROGARD PLN RD THERE WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "WE HAVE BEEN FACING TROUBLES WITH THE NO ADDITIVE TUBE W/MICROGARD COLOR RED STOPPER. THE ISSUE IT PRESENTS IS THAT THE SAMPLE, AFTER BEING CENTRIFUGED, SUFFERS HEMOLYSIS. ACCORDING TO CUSTOMER, IT HAS BEEN DISCARDED IF IT COULD HAS BEEN CAUSED BY THE SAMPLE TAKING, THE ROTATION, AND THE TIME IN CENTRIFUGE, NOR AN IMPROPER HANDLING OF THE SAMPLE. CUSTOMER CONCLUDED THAT THE ISSUE REGARDS THE TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11314594 ↗
• MalfunctionMar 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THE BD MICROTAINER® Z (NO ADDITIVE TUBES) HAD INCORRECT ADDITIVE AND CLOTTING / MICRO-CLOTS/FIBRIN CLOTS (TUBES THAT ARE NOT SUPPOSED TO CLOT) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EDTA OR STREK SOLUTION WAS ADDED TO THE TUBE BUT IT WAS STILL CLOTTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9811814 ↗
• MalfunctionJun 13, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT TUBES WERE NOT CLOTTING AFTER USE WITH A BD MICROTAINER® Z (NO ADDITIVE TUBES). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 365963 BATCH NO:8155792 (1 OF 2). IT WAS REPORTED THE CUSTOMER WAS EXPERIENCING TUBES NOT CLOTTING. FOUND OUT ABOUT THE RECALL AFTER EXPERIENCING ISSUES. THIS HAS BEEN OCCURRING FOR A COUPLE WEEKS, NO SPECIFIC DATES KNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8697259 ↗
• MalfunctionDec 17, 2018Leak/Splash; Component Missing; Leak/Splash; Component Missing

  IT WAS REPORTED THAT A BD MICROTAINER® Z (NO ADDITIVE TUBES) HAD A SAMPLE THAT DID NOT CLOT, AND THE CAP DOES NOT LOCK COMING OUT EASILY AND AUTOMATICALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8170137 ↗
• MalfunctionJun 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD MICROTAINER® Z (NO ADDITIVE TUBES) EXHIBITED HEMOLYSIS. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7562340 ↗
• MalfunctionJun 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD MICROTAINER® Z (NO ADDITIVE TUBES) HAD SERUM THAT WASN¿T SEPARATING FROM THE CELLS AFTER CENTRIFUGATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7561596 ↗
• MalfunctionMay 4, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD MICROTAINER® Z (NO ADDITIVE TUBES) "MICRO - 365963 - TUBES WITH WATER (LA)".

  Patient problems: No Information

  MAUDE report 7488896 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991702. One submission often covers many models, so check the product and lot details in each record.

• Z-0055-2020 · May 13, 2019 · Terminated
  BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
• Z-0060-2020 · May 13, 2019 · Terminated
  BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
• Z-0056-2020 · May 13, 2019 · Terminated
  BD Microtainer SST Part/Catalog No.365967
• Z-0057-2020 · May 13, 2019 · Terminated
  BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
• Z-0059-2020 · May 13, 2019 · Terminated
  BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
• Z-0061-2020 · May 13, 2019 · Terminated
  BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
• Z-0058-2020 · May 13, 2019 · Terminated
  BD Microtainer SST- Amber Part/Catalog Number: 365978
• Z-1603-05 · Aug 20, 2004 · Terminated
  BD Vacutainer Microtainer Serum tubes (with or without gel).