BD Microtainer® Tubes with LH (Lithium Heparin) 365965Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 30382903659655), received between May 1, 2018 and Oct 30, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 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-0055-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO USE OF BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN), 200 MICROTAINERS HAD FOREIGN MATTER(FM) AND MELTED/DEFORMED CAPS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567764 ↗
• MalfunctionSep 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) 15 SAMPLES WERE CLOTTED. THE CUSTOMER INDICATED TUBES WERE UNDERFILLED AND OVERFILLED. THE CUSTOMER INDICATED THE CLOTTED SAMPLES WERE DUE TO IMPROPER COLLECTION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197058 ↗
• MalfunctionJun 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Component Missing; Incorrect, Inadequate or Imprecise Result or Readings; Component Missing

  IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) 10 TUBES ARE CLOTTING AND ARE MISSING ADDITIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639403 ↗
• MalfunctionJun 22, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE SAMPLES ARE HEMOLYZED WITH A BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED EXPERIENCING HEMOLYZED SPECIMENS WHEN USING LOTS 925441N AND 927410N. THIS STARTED OCCURRING WITHIN THE LAST 3 MONTHS, NO SPECIFIC AMOUNT OF SPECIMENS AFFECTED. CUSTOMER STATES THERE ARE NO REPORTS OF ERRONEOUS RESULTS AS THEY ARE THE DRAWING LAB. NO REPORTS FROM TESTING LAB OF ERRONEOUS RESULTS. SHE WILL BE CONDUCTING DRAWS TODAY SO PHOTOS MAY BE AVAILABLE AFTER TODAY. THOUGH SHE DID CONFIRM UNUSED TUBES ARE AVAILABLE FOR INVESTIGATION NOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10179775 ↗
• MalfunctionJun 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT 6 BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) WERE BELIEVED TO BE SODIUM LITHIUM TUBES AND USED FOR CYTOGENETIC TESTING, WHERE THEY WERE REJECTED BY THE CLINIC FOR "LITHIUM US CYTOTOXIC". THE ISSUE WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED THE 6 GREEN TOP MICROTAINERS HAD BEEN DRAWN AT THE NEXT-DOOR CHILDREN'S HOSPITAL AND SENT TO THE CLINIC FOR GENETIC TESTING, ONLY TO BE TOLD THEY WERE UNACCEPTABLE B/C LITHIUM US CYTOTOXIC. I TOLD HIM SODIUM HEPARIN MICROTAINERS ARE NOT AVAILABLE AT THIS TIME, AND WE HAVE NO DATA SUPPORTING THE USE OF LITHIUM HEPARIN FOR CYTOGENETIC TESTING. I TOLD HIM A 2.0 ML VACUTAINER IS AVAILABLE WITH SODIUM HEPARIN, AND MAY BE USED WHEN VENOUS BLOOD IS DRAWN FROM NEONATES, TYPICALLY FROM CENTRAL LINES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164857 ↗
• MalfunctionNov 11, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MATERIAL NO. 365965 BATCH NO. 910158N, 912391N IT WAS REPORTED THAT DURING USE OF THE BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) THERE IS DECREASED CO2 RESULTS WHEN USING BD MICROTAINER TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINED OF HAVING DECREASED CO2 RESULTS USING BD MICROTAINER GREEN TOP TUBES. THEY ARE STILL INVESTIGATING THE CAUSE AND HAVE CONFIRMED THE ISSUE IS NOT FROM THEIR REAGENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9306087 ↗
• MalfunctionJul 11, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT THE SAMPLE COLLECTED FOR BILIRUBIN IN THE BD MICROTAINER® TUBE WITH LH (LITHIUM HEPARIN) CLOTTED DURING USE, BUT WAS RUN THROUGH THE ANALYZER REGARDLESS "WITH NO ISSUES". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOKE WITH CUSTOMER AND THEY HAD 2-3 SAMPLES THAT WERE CLOTTED IN THE MICROTAINER TUBES. THEY WERE COLLECTED FOR BILIRUBIN. HE FEELS IT IS A COLLECTION ISSUE BY THE NURSES, THAT THEY ARE NOT MIXING THEM CORRECTLY. SAMPLES WERE NOT HEMOLYSED. THEY DID RUN SAMPLES WITH NO ISSUES AND HAVE VALIDATED THE BILIRUBIN TEST ON SERUM SAMPLES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781572 ↗
• MalfunctionMay 23, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MATERIAL NO. 365965. BATCH NO. UNKNOWN. IT WAS REPORTED THAT AFTER USE OF THE BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) THERE WERE ISSUES WITH HEMOLYSIS. THERE WERE THREE OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS 3 INCIDENTS THAT INVOLVED HEMOLYSIS ON (B)(6) WITH PRODUCT 365965/UNKNOWN LOT. NO PATIENT IDENTIFIERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8638434 ↗
• MalfunctionApr 30, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT SAMPLE COLLECTED IN THE BD MICROTAINER® TUBE WITH LH (LITHIUM HEPARIN) CLOTTED. THIS COMPLAINT WAS CREATED TO CAPTURE 1 OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TUBES WERE CLOTTING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8565546 ↗
• MalfunctionApr 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) WERE CLOTTING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 365965, BATCH NO. 830556N. IT WAS REPORTED THAT THE TUBES WERE CLOTTING. THE TUBES WERE CLOTTING. DATE OF EVENT: (B)(6) 2019 (2 OF 2). DATES OF EVENT: (B)(6) 2019: NO PATIENT IDENTIFIERS, UNKNOWN LOT, NO SAMPLES. (B)(6) 2019: FEMALE, 18 YRS OLD, LOT 830556N, SAMPLES AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8565432 ↗
• MalfunctionJan 11, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A BD MICROTAINER® TUBES WITH LH DID NOT SEPARATE PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8242138 ↗
• MalfunctionJun 14, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) HAD HEMOLYSIS. NO SERIOUS INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7603559 ↗
• MalfunctionJun 14, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) HAD CRACKED CAPS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601242 ↗
• MalfunctionJun 12, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) PROVIDED ERRONEOUS RESULTS. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7594389 ↗
• MalfunctionMay 2, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) CONTAINED CLOTS WHICH COULD CAUSE ERRONEOUS RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481589 ↗
• MalfunctionMay 1, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN) WERE UNDER FILLING.

  Patient problems: No Information

  MAUDE report 7475850 ↗

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-0059-2020 · May 13, 2019 · Terminated
  BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
• Z-0058-2020 · May 13, 2019 · Terminated
  BD Microtainer SST- Amber Part/Catalog Number: 365978
• Z-0061-2020 · May 13, 2019 · Terminated
  BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
• 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-1603-05 · Aug 20, 2004 · Terminated
  BD Vacutainer Microtainer Serum tubes (with or without gel).