BD Microtainer® SST™ - Amber 365978Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 30382903659785), received between May 2, 2018 and Apr 23, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 reports).

2 FDA recall records name this device's identifier, 1 still open.

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 25, 2022Class IIOpen, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1618-2022 · Root cause: Environmental control · Recall details · FDA record ↗

2. 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-0058-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE WITH THE BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN), AN UNSPECIFIED NUMBER OF TUBES HAD ISSUES WITH GEL SMEARING. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168962 ↗
• MalfunctionMar 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿- AMBER, POOR BARRIER SEPARATION OCCURRED WITH ONE TUBE. THE TUBE WAS RECENTRIFUGED AND THE BARRIER STILL DID NOT MOVE, CAUSING THE SERUM TO NOT BE ABLE TO BE ANALYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894213 ↗
• MalfunctionDec 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE WITH BD MICROTAINER® SST¿ - AMBER, THE TUBES WERE LABELED AS THE INCORRECT PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352745 ↗
• MalfunctionNov 14, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿ - AMBER TUBE ARE HEMOLYZING. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131545 ↗
• MalfunctionApr 2, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT PRIOR TO USE WITH BD MICROTAINER® SST¿ - AMBER HAD ABNORMAL ADDITIVE, IT APPEARED "MELTED/STICKY". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES COATING IN THE MIDDLE OF THE TUBE IS MELTED/STICKY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661104 ↗
• MalfunctionMar 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT TUBES ARE NOT SEPARATING AFTER CENTRIFUGATION WITH AN BD MICROTAINER® SST¿ AMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN HAVING ISSUES WITH OUR SERUM SEPARATOR MICROTAINERS THAT WE USE FOR NEONATAL BILIRUBIN'S. WE ARE CENTRIFUGING THEM FOR 10 MIN AT 3000 RPM AND THEY ARE NOT SEPARATING. WE WILL ONLY GET MAYBE A DROP OF SERUM OUT, SO WE CENTRIFUGE THEM AGAIN FOR THE 10 MIN AT 3000 AND MOST OF THE TIME THEN ARE OK THEN. ADDITIONALLY, ON (B)(6) 2020 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: SPOKE WITH THE CUSTOMER AND EXPLAINED THAT SHE IS NOT CENTRIFUGING THE MICROTAINERS AT THE CORRECT SPEED AND TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9884614 ↗
• MalfunctionJan 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS POOR BARRIER SEPARATION AFTER USE WITH A BD MICROTAINER® SST¿ - AMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED BY CUSTOMER ONE VACUTAINER EXPERIENCED POOR BARRIER SEPARATION. ADDITIONAL INFORMATION RECEIVED 2020-01-10 FROM CUSTOMER: SHE STATES THAT THE MICROTAINER WAS A HEELSTICK DRAW BY A NURSE ON THE OB FLOOR FROM A (B)(6) BABY. SHE IS NOT CERTAIN IF THE NURSE MIXED THE TUBE. IT WAS SPUN IN A DRUCKER APEX 6 AT 5306 RPM FOR 3 MINUTES, THEN AGAIN FOR 5 MINUTES, WITH POOR SEPARATION, AND THEN SPUN IN A THERMOFISHER CENTRIFUGE AT 3200 RPM FOR 10 MINUTES. AT THIS POINT, THERE WAS ENOUGH SERUM TO RUN THE BILIRUBIN TEST. THEY USUALLY DON'T HAVE PROBLEMS WITH MICROTAINER SAMPLES, AND USUALLY SEPARATE WELL AFTER THE FIRST SPIN. I EXPLAINED THAT IT IS IMPORTANT TO MIX THE TUBES ONCE THEY ARE COLLECTED, SINCE THERE IS CLOT ACTIVATOR IN THE TUBE, AND TO CENTRIFUGE AT 6000 - 15,000 G FOR 90 SECONDS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9644697 ↗
• MalfunctionJun 13, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD MICROTAINER® SST¿ - AMBER WOULDN'T CLOT AFTER USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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 8695757 ↗
• MalfunctionMay 23, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MATERIAL NO.: 365978. BATCH/LOT: 8262866. IT WAS REPORTED THAT DURING USE OF THE BD MICROTAINER® SST¿ - AMBER "TWO DIFFERENT SPECIMENS WERE COLLECTED AND SPUN GEL DID NOT MIGRATE ON EITHER SPECIMEN AFTER FIRST SPIN". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER TEXT: 2 MICROTAINER TUBES COLLECTED. ONE TUBE MIGRATED AND ONE DID NOT. LOT: 8262866 EXP: 11/30/19 TWO DIFFERENT SPECIMENTS WERE COLLECTED AND SPUN GEL DID NOT MIGRATE ON EITHER SPECIMENT AFTER FIRST SPIN. SO BOTH SPECIMENTS IMMEDIATELY SPUN A SECOND TIME - ONE OF THEM MIGRATED AND ONE DID NOT. SPECIMENT THAT DID NOT MIGRATE WAS SPUN A THIRD AND A FOURTH TIME AND STILL DID NOT MIGRATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8635756 ↗
• MalfunctionApr 22, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD MICROTAINER® SST¿ - AMBER HAD POOR SEPARATOR MOVEMENT. THIS OCCURRED ON 3 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PART NO.: 365978. BATCH/LOT: 8208542. IT WAS REPORTED THAT THE "GEL IS SITTING AT THE BOTTOM OF TUBE AFTER SPINNING AND NOT MIGRATING TO SEPARATE RED CELLS FROM SERUM.". ORIGINAL TEXT: TUBES WERE SPUN BEFORE SENDING TO LAB. COLLECTED AT ONE SITE AND SENT ANOTHER FOR TESTING. TWO OF THE SPECIMENS SPUN AND SENT OUT WITH A COURIER SEVERAL HOURS LATER. ONE SPECIMEN SPUN AND SENT OUT STAT SO THAT ONE WAS ABLE TO BE RESPUN AND TESTED. GEL IS SITTING AT THE BOTTOM OF TUBE AFTER SPINNING AND NOT MIGRATING TO SEPARATE RED CELLS FROM SERUM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535950 ↗
• MalfunctionJan 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USE OF THE BD MICROTAINER® SST¿ AMBER THE TUBE IS CLOTTING AND HEMOLYZING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8257493 ↗
• MalfunctionJun 11, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD MICROTAINER® SST¿ - AMBER EXHIBITED POOR BARRIER SEPARATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589156 ↗
• MalfunctionJun 8, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT THE GEL IN THE BD MICROTAINER® SST¿ - AMBER DID NOT SEPARATE THE CLOT FROM THE SERUM PROPERLY. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7582790 ↗
• MalfunctionJun 4, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD MICROTAINER® SST¿ - AMBER TUBES DIDN¿T HAVE ENOUGH SERUM IN THEM. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7567667 ↗
• MalfunctionMay 23, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED WHILE USING BD MICROTAINER® SST¿ - AMBER, THAT THE GEL WOULD NOT MOVE TO SEPARATE THE SERUM WHILE BEING CENTRIFUGED.

  Patient problems: No Information

  MAUDE report 7537443 ↗
• MalfunctionMay 17, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD MICROTAINER® SST¿ AMBER TUBES 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 7524073 ↗
• MalfunctionMay 2, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THE BD MICROTAINER® SST¿ - AMBER WERE HAVING POOR SEPARATION., NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481548 ↗

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-0061-2020 · May 13, 2019 · Terminated
  BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
• 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-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-0059-2020 · May 13, 2019 · Terminated
  BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
• Z-0056-2020 · May 13, 2019 · Terminated
  BD Microtainer SST Part/Catalog No.365967
• Z-1603-05 · Aug 20, 2004 · Terminated
  BD Vacutainer Microtainer Serum tubes (with or without gel).