BD Microtainer® PST™ Tubes with LH (Lithium Heparin) - Amber 365987Recalls & reported problems
Becton, Dickinson And Company · TUBE MICRO W/MICROGARD PST MTGN/AMB · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Microtainer PST tube is a small amber blood collection vial used to draw and store blood samples. The 27 reports mostly describe tubes arriving with gel or liquid problems — gel liquefying or smearing inside the cap or along the tube, leaking or splashing, and samples giving unreliable results; no deaths and no injuries were reported. One recall, since closed, concerned a damaged reservoir that could leave too little blood in the tube for testing.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 30382903659877), received between Dec 3, 2017 and Sep 5, 2025 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (6 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.
Reports received per month
Recalls naming this device
- 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-0060-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Ingredient or Reagent Problem6
- Leak/Splash6
- Incorrect, Inadequate or Imprecise Result or Readings5
- Coagulation in Device or Device Ingredient2
- Incorrect Or Inadequate Test Results2
- Device Contamination with Chemical or Other Material1
- Excessive Heating1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient4
- No Information3
- Blood Loss1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED PRIOR TO USE OF BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) - AMBER, AN UNSPECIFIED NUMBER OF MICROTAINERS WERE STORED AT AN INCORRECT TEMPERATURE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22978861 ↗MalfunctionJun 30, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USE OF BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) - AMBER ,1 TUBE CONTAINED LIQUID GEL (YELLOW STICKY VISCOUS FLUID). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22367162 ↗MalfunctionJun 5, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USE OF BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) - AMBER, AN UNSPECIFIED NUMBER OF TUBES CONTAIN LIQUID OR SOFTER GEL THAT IS EITHER FOUND IN THE CAP OR SMEARED UP THE SIDE OF THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22155742 ↗MalfunctionJun 5, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USE OF BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) - AMBER, AN UNSPECIFIED NUMBER OF TUBES CONTAIN LIQUID OR SOFTER GEL THAT IS EITHER FOUND IN THE CAP OR SMEARED UP THE SIDE OF THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22155741 ↗MalfunctionJun 5, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USE OF BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) - (B)(6), AN UNSPECIFIED NUMBER OF TUBES CONTAIN LIQUID OR SOFTER GEL THAT IS EITHER FOUND IN THE CAP OR SMEARED UP THE SIDE OF THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22155740 ↗MalfunctionMay 28, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USE OF BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN): AMBER, 1 TUBE CONTAINED LIQUID GEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22097287 ↗MalfunctionMay 21, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USE OF BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) - AMBER, AN UNSPECIFIED NUMBER OF TUBES CONTAINED LIQUEFIED GEL IN THE CAP. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22065360 ↗MalfunctionFeb 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED PRIOR TO USE OF BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) - AMBER, 6 TUBES HAD ABNORMAL GEL SMEARING THAT WAS LEAKING OUT OF THE TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405269 ↗MalfunctionAug 20, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem
IT WAS REPORTED WHEN USING THE BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN), THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IS THERE ONLY ONE SIZE AVAILABLE FOR THE MICROTAINER TUBES? THE NEW CHEMISTRY ANALYZERS USE MORE PLASMA, AND WE ARE SEEING A HIGH NUMBER OF QNS DRAWS ON BABIES. THEY HAVE BEEN TRYING TO DRAW 2 TUBES, BUT THE PARENTS ARE GETTING ANGRY. I AM WONDERING IF WE CAN JUST GET THEM A BIGGER TUBE TO USE AND THEY WON¿T HAVE TO FILL THE ENTIRE THING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12350668 ↗MalfunctionAug 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AFTER USE THE BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED 3 INCIDENTS IN THE PAST WEEK WHERE BLOOD WAS COLLECTED FROM A NEONATE IN A REGULAR SYRINGE (NO ADDITIVE) AND PUT IN A GREEN MICROTAINER. WHEN THE CHEMISTRIES WERE TESTED IN THE LAB, WE OBTAINED POTASSIUM RESULTS >10 AND CALCIUM RESULTS <5. THESE RESULTS GENERALLY SUGGEST CHELATION OF CALCIUM. HOWEVER, IN THESE CASES, NO OTHER TUBES (INCLUDING EDTA) WERE COLLECTED (ONLY THE GREEN). THE STAFF MEMBERS WHO COLLECTED THE BLOOD ARE VERY WELL VERSED IN NEONATAL COLLECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10375741 ↗MalfunctionAug 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AFTER USE THE BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED 3 INCIDENTS IN THE PAST WEEK WHERE BLOOD WAS COLLECTED FROM A NEONATE IN A REGULAR SYRINGE (NO ADDITIVE) AND PUT IN A GREEN MICROTAINER. WHEN THE CHEMISTRIES WERE TESTED IN THE LAB, WE OBTAINED POTASSIUM RESULTS >10 AND CALCIUM RESULTS <5. THESE RESULTS GENERALLY SUGGEST CHELATION OF CALCIUM. HOWEVER, IN THESE CASES, NO OTHER TUBES (INCLUDING EDTA) WERE COLLECTED (ONLY THE GREEN). THE STAFF MEMBERS WHO COLLECTED THE BLOOD ARE VERY WELL VERSED IN NEONATAL COLLECTION
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10373596 ↗MalfunctionMar 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED RELATED TO THE GEL AND DRUG INTERACTIONS WITH A BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 4 COMPLAINTS) IT WAS REPORTED THAT THERE IS ISSUES RELATED TO THE GEL AND DRUG INTERACTIONS WITH THERAPEUTIC DRUG MONITORING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9811542 ↗MalfunctionApr 12, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BLOOD WAS FOUND IN CENTRIFUGE TUBE WITH A BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BLOOD WAS FOUND IN CENTRIFUGE TUBE BUCKET. LEADING STAFF TO BELIEVE IT WENT THROUGH PLASTIC WHILE SPINNING. PLASMA AND GEL SEPARATOR STILL INTACT IN TUBE. CUSTOMER REPORTED, - "WHEN TAKING SAMPLE OUT OF CENTRIFUGE, NOTICED THAT BOTTOM OF TUBE WAS BLOODY. THE CENTRIFUGE WELL THAT SAMPLE WAS IN WAS FULL OF BLOOD. APPEARED AS IF RED CELLS WERE FORCED OUT BOTTOM OF TUBE DURING CENTRIFUGATION (PLASMA AND GEL STILL IN TUBE). HAPPENED ON TWO SEPARATE OCCASIONS <1 MONTH APART IN TWO DIFFERENT WELLS IN THE CENTRIFUGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8508805 ↗MalfunctionMar 21, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING USE OF THE BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) THERE WAS AN ISSUE OF LEAKAGE. THERE WERE TWO ADDITIONAL REPORTS OF LEAKAGE SINCE THESE TWO WERE REPORTED WE HAVE HAD 2 MORE INCIDENTS THAT I AM AWARE OF. ONE ON FEB 9TH AND ONE ON FEB 10TH. FEB 9TH ¿ ONLY INFORMATION I HAVE IS THAT IT WAS A BABY AND THE SAMPLE WAS RECOLLECTED. TUBE WAS NOT SAVED. FEB 10TH ¿ PATIENT WAS AN 87 YEAR OLD FEMALE FROM EMERGENCY DEPARTMENT. SAMPLE WAS ANALYZED FOR CK AND TROPONIN ON ROCHE COBAS. RESULTS WERE REPORTED. [CK ¿ 29 (RANGE 28-110), HTNT ¿ 18 (RANGE <14)] EMPTY TUBE IS AVAILABLE. BOTH OF THESE WOULD HAVE ALSO RESULTED IN EXPOSURE AND CLEANUP OF BLOOD SPILL IN CENTRIFUGE. ALL OF THESE SAMPLES WERE SPUN IN THE SAME CENTRIFUGE BUT EACH ONE WAS IN A DIFFERENT POSITION. ALL WERE THE SAME LOT # 827652N. THERE HAVE BEEN NO MORE INCIDENTS THAT I AM AWARE OF SINCE FEB 10TH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8440249 ↗MalfunctionMar 20, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) LEAKED. REPORTED BY CUSTOMER: SINCE THESE TWO WERE REPORTED WE HAVE HAD 2 MORE INCIDENTS THAT I AM AWARE OF. ONE ON (B)(6) AND ONE ON (B)(6). (B)(6) ¿ ONLY INFORMATION I HAVE IS THAT IT WAS A BABY AND THE SAMPLE WAS RECOLLECTED. TUBE WAS NOT SAVED. (B)(6) ¿ PATIENT WAS AN (B)(6) YEAR OLD FEMALE FROM EMERGENCY DEPARTMENT. SAMPLE WAS ANALYZED FOR CK AND TROPONIN ON ROCHE COBAS. RESULTS WERE REPORTED. [CK ¿ 29 (RANGE 28-110), HTNT ¿ 18 (RANGE <14)] . EMPTY TUBE IS AVAILABLE. BOTH OF THESE WOULD HAVE ALSO RESULTED IN EXPOSURE AND CLEANUP OF BLOOD SPILL IN CENTRIFUGE. ALL OF THESE SAMPLES WERE SPUN IN THE SAME CENTRIFUGE BUT EACH ONE WAS IN A DIFFERENT POSITION. ALL WERE THE SAME LOT # 827652N. THERE HAVE BEEN NO MORE INCIDENTS THAT I AM AWARE OF SINCE (B)(6).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8435970 ↗MalfunctionMar 6, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BLOOD WAS FOUND ON THE BOTTOM OF THE OUTSIDE OF THE BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) AFTER CENTRIFUGATION. THE SAMPLE SPUN HAD BEEN COLLECTED FROM A BABY FOR "TB", AND THE WELL THE SAMPLE WAS SPUN IN WAS FOUND "FULL OF BLOOD". HOWEVER, UPON VISUAL INSPECTION, THE CUSTOMER DID NOT FIND ANY CRACKS OR HOLES IN THE BOTTOM OF THE TUBE. THE WARD WAS REPORTEDLY NOTIFIED AND A NEW SAMPLE WAS COLLECTED. AS REPORTED BY THE CUSTOMER, "[LAB] - BABY SAMPLE FOR TB WAS COLLECTED IN A3NN BY L6MQ AT 0827 ((B)(6)). SAMPLE WAS RECEIVED IN LAB AND PUT TO SPIN. WHEN REMOVING SAMPLE FROM CENTRIFUGE IT WAS NOTICED THAT THERE WAS BLOOD ON THE OUTSIDE BOTTOM OF THE TUBE. THE CENTRIFUGE WELL (SPOT 3) THAT THE SAMPLE WAS IN WAS FULL OF BLOOD. IT APPEARED AS IF RED CELLS WERE FORCED OUT THE BOTTOM OF THE TUBE DURING CENTRIFUGATION AS THE PLASMA AND GEL WERE STILL IN THE TUBE. I EXAMINED THE MICROTAINER BUT COULD NOT SEE ANY CLEARLY VISIBLE SIGNS OF ANY CRACKS/HOLES. THIS WAS THE SECOND TIME IN LESS THAN A MONTH THAT THIS OCCURRED. BOTH TUBES WERE THE SAME LOT # (827652N) AND WERE SPUN IN DIFFERENT WELLS OF THE CENTRIFUGE. IMMEDIATE ACTIONS WARD WAS NOTIFIED AND SAMPLE
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8396397 ↗MalfunctionMar 6, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) HAD BLOOD ON THE OUTSIDE BOTTOM OF THE TUBE AFTER CENTRIFUGATION. THERE WAS EXPOSURE TO BLOOD UPON REMOVAL OF TUBE FROM CENTRIFUGE. THE LEAK WAS CLEANED FOLLOWING LAB PROCEDURES. NO SERIOUS INJURY WAS REPORTED. VERBATIM: "MATERIAL NO. 365987, BATCH NO. 827652N. IT WAS REPORTED THAT THERE WAS BLOOD ON THE OUTSIDE BOTTOM OF THE TUBE AFTER CENTRIFUGATION. (B)(6)- BABY SAMPLE FOR TB WAS COLLECTED IN A3NN BY L6MQ AT 0827 ((B)(4)). SAMPLE WAS RECEIVED IN LAB AND PUT TO SPIN. WHEN REMOVING SAMPLE FROM CENTRIFUGE IT WAS NOTICED THAT THERE WAS BLOOD ON THE OUTSIDE BOTTOM OF THE TUBE. THE CENTRIFUGE WELL (SPOT 3) THAT THE SAMPLE WAS IN WAS FULL OF BLOOD. IT APPEARED AS IF RED CELLS WERE FORCED OUT THE BOTTOM OF THE TUBE DURING CENTRIFUGATION AS THE PLASMA AND GEL WERE STILL IN THE TUBE. I EXAMINED THE MICROTAINER BUT COULD NOT SEE ANY CLEARLY VISIBLE SIGNS OF ANY CRACKS/HOLES. THIS WAS THE SECOND TIME IN LESS THAN A MONTH THAT THIS OCCURRED. BOTH TUBES WERE THE SAME LOT # (827652N) AND WERE SPUN IN DIFFERENT WELLS OF THE CENTRIFUGE. IMMEDIATE ACTIONS WARD WAS NOTIFIED AND SAMPLE WAS RECOLLECTED. A PRODUCT COMPLAINT HAS
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8396090 ↗MalfunctionJan 4, 2019Coagulation in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings; Coagulation in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) CLOTTED AND PATIENTS HAD TO BE REDRAWN. THERE WERE MULTIPLE LOTS INVOLVED IN THIS INCIDENT. LOT# 824092N WAS REPORTED TO HAVE 1 OCCURRENCE, AND LOT# 822855N WAS REPORTED TO HAVE 1 OCCURRENCE.
Patient problems: No Information
MAUDE report 8219364 ↗MalfunctionDec 20, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED THAT BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) HAD CLOTTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8187104 ↗MalfunctionJun 4, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD MICROTAINER® PST¿ TUBES WITH LH LITHIUM HEPARIN HAD A STICKY SUBSTANCE INSIDE THE TUBE WITH A STRINGY SUBSTANCE ATTACHED TO THE CAP.
Patient problems: No Information
MAUDE report 7567412 ↗MalfunctionApr 26, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results
IT WAS REPORTED THAT WHILE USING THE BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) THAT THE GEL WAS IN THE WRONG SPOT AND APPEARED "MELTED".
Patient problems: No Information
MAUDE report 7465878 ↗MalfunctionApr 16, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results
IT WAS REPORTED THAT SEVERAL BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) SUFFERED FROM ¿MELTED GEL¿. PER THE CUSTOMER ¿SOMEHOW, THE GEL SEPARATOR HAS GONE TO THE TOP OF SOME UNUSED TUBES, INTO THE LID, AND MADE ITS WAY AROUND THE TOP SCOOP PART OF THE TUBE INCLUDING THE OUTSIDE SURFACE¿. THE SPECIMENS REQUIRED RECOLLECTIONS, BUT THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7434612 ↗MalfunctionDec 8, 2017Melted
IT WAS REPORTED THAT A BD MICROTAINER® WITH LITHIUM HEPARIN AND PLASMA SEPARATOR ADDITIVE HAD "MELTED GEL". THE GEL SEPARATOR HAS GONE TO THE TOP OF SOME UNUSED TUBES, INTO THE LID, AND MADE ITS WAY AROUND THE TOP SCOOP PART OF THE TUBE INCLUDING THE OUTSIDE SURFACE. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7100775 ↗MalfunctionDec 8, 2017Gel Leak
IT WAS REPORTED THAT BD MICROTAINER® PST AMBER TUBES HAD NO GEL IN THE TUBE. NO INJURY OR MEDICAL INTERVENTION REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7099596 ↗MalfunctionDec 5, 2017Fluid/Blood Leak
IT WAS REPORTED THAT AFTER BLOOD COLLECTION, A NICU NURSE NOTICED PLASMA LEAKAGE FROM A BD MICROTAINER TUBE WITH BD MICROGARD CLOSURE, PST AMBER, LITHIUM HEPARIN W/GEL ADDITIVE, AFTER CENTRIFUGATION. THE TUBE WAS HANDCARRIED TO THE LAB AND PUT IN ANOTHER PLASTIC TUBE. THE TUBE WAS THEN PLACED INTO A STATSPIN FOR THREE MINUTES. AFTER SPINNING, PROCESSING PERSON PICKED UP MICROTAINER FROM TUBE WITH A FORCEP BUT NOTICED THAT THERE WASN'T ENOUGH SPECIMEN AND BLOOD WAS LEAKING FROM THE BASE OF THE MICROTAINER TUBE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7085014 ↗
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-0057-2020 · May 13, 2019 · TerminatedBD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
- Z-0059-2020 · May 13, 2019 · TerminatedBD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
- Z-0055-2020 · May 13, 2019 · TerminatedBD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
- Z-0058-2020 · May 13, 2019 · TerminatedBD Microtainer SST- Amber Part/Catalog Number: 365978
- Z-0054-2020 · May 13, 2019 · TerminatedBD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
- Z-0056-2020 · May 13, 2019 · TerminatedBD Microtainer SST Part/Catalog No.365967
- Z-0061-2020 · May 13, 2019 · TerminatedBD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
- Z-1603-05 · Aug 20, 2004 · TerminatedBD Vacutainer Microtainer Serum tubes (with or without gel).
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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.
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