BD Microtainer® SST™ 365967Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 30382903659679), received between Dec 4, 2017 and Oct 31, 2025 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (17 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 16, 2026.

Recalls naming this device

1. May 13, 2019Terminated

   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-0056-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD MICROTAINER® SST¿, AN UNSPECIFIED NUMBER OF MICROTAINERS HAVE A SEAL ISSUE WITH THE CAP. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23440673 ↗
• MalfunctionJul 16, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED PRIOR TO USE OF BD MICROTAINER® SST¿, 1 TUBE HAD THE GEL AT THE TOP OF THE TUBE INSTEAD OF THE BOTTOM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519744 ↗
• MalfunctionMar 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD MICROTAINER® SST¿ , 6 TUBES EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586137 ↗
• MalfunctionOct 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD MICROTAINER® SST¿ TUBES AN UNSPECIFIED NUMBER OF TUBES HAD GEL THAT WAS AN UNEXPECTED COLOR, AND THE SAMPLES DID NOT SEPARATE CORRECTLY AFTER CENTRIFUGATION. NO RESULTS COULD BE PROVIDED FOR BILIRUBIN. NO OTHER HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462714 ↗
• MalfunctionJul 30, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING BD MICROTAINER® SST¿ THE SAMPLES ARE NOT CLOTTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: IT WAS REPORTED BY THE CUSTOMER THAT SAMPLES ARE NOT CLOTTING. TUBES WILL OCCASIONALLY NOT CLOT AFTER 30 MIN. APPROXIMATELY 6 SAMPLES AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421815 ↗
• MalfunctionJun 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿ CUSTOMER USED AN EXPIRED TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT TUBE MAT# 365967 USE AT EXPIRATION. SM 365967 USE AT EXPIRATION INQUIRY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130978 ↗
• MalfunctionJan 28, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT AFTER CENTRIFUGATION WITH 2 LOTS OF BD MICROTAINER® SST¿ THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT AFTER CENTRIFUGATION, THERE IS NO SERUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261236 ↗
• MalfunctionJan 25, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT DURING USE WITH BD MICROTAINER® SST¿ 1 OUT OF 9 SAMPLES HAD NO SERUM OBTAINED AFTER CENTRIFUGATION. THE PATIENT WAS RE-COLLECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS THE 5TH OF 5 OCCURRENCES. IT WAS REPORTED BY THE CUSTOMER NO SERUM OBTAINED AFTER CENTRIFUGATION WE TRIED SPINNING USING THE HORIZONTAL SWING BUCKET INSTEAD OF THE FIXED ANGLED, SAME OUTCOME ON 10% OF THE SAMPLES. WE ARE SUSPECTING PERHAPS THESE SPECIMENS MIGHT HAVE BEEN GROSSLY HEMOLYZED SUCH THAT IT AFFECTS THE DENSITY AND THUS THE GEL SEPARATION. DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? YES. DID EXPOSURE TO BLOOD/ BF OCCUR? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244224 ↗
• MalfunctionJan 25, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT DURING USE WITH BD MICROTAINER® SST¿ OUT OF 4 SAMPLES HAD NO SERUM OBTAINED AFTER CENTRIFUGATION. THE PATIENT WAS RE-COLLECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS THE 4TH OF 5 OCCURRENCES. IT WAS REPORTED BY THE CUSTOMER NO SERUM OBTAINED AFTER CENTRIFUGATION WE TRIED SPINNING USING THE HORIZONTAL SWING BUCKET INSTEAD OF THE FIXED ANGLED, SAME OUTCOME ON 10% OF THE SAMPLES. WE ARE SUSPECTING PERHAPS THESE SPECIMENS MIGHT HAVE BEEN GROSSLY HEMOLYZED SUCH THAT IT AFFECTS THE DENSITY AND THUS THE GEL SEPARATION. · DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? YES. · DID EXPOSURE TO BLOOD/ BF OCCUR? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244222 ↗
• MalfunctionJan 25, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT DURING USE WITH BD MICROTAINER® SST¿ 2 OUT OF 9 SAMPLES HAD NO SERUM OBTAINED AFTER CENTRIFUGATION. THE PATIENTS WERE RE-COLLECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS THE 1ST OF 5 OCCURRENCES. IT WAS REPORTED BY THE CUSTOMER NO SERUM OBTAINED AFTER CENTRIFUGATION WE TRIED SPINNING USING THE HORIZONTAL SWING BUCKET INSTEAD OF THE FIXED ANGLED, SAME OUTCOME ON 10% OF THE SAMPLES. WE ARE SUSPECTING PERHAPS THESE SPECIMENS MIGHT HAVE BEEN GROSSLY HEMOLYZED SUCH THAT IT AFFECTS THE DENSITY AND THUS THE GEL SEPARATION. · DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? YES. DID EXPOSURE TO BLOOD/ BF OCCUR? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244219 ↗
• MalfunctionJan 25, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT DURING USE WITH BD MICROTAINER® SST¿ 2 OUT OF 10 SAMPLES NO SERUM OBTAINED AFTER CENTRIFUGATION. THE PATIENTS WERE RE-COLLECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS THE 2ND OF 5 OCCURRENCES. IT WAS REPORTED BY THE CUSTOMER NO SERUM OBTAINED AFTER CENTRIFUGATION WE TRIED SPINNING USING THE HORIZONTAL SWING BUCKET INSTEAD OF THE FIXED ANGLED, SAME OUTCOME ON 10% OF THE SAMPLES. WE ARE SUSPECTING PERHAPS THESE SPECIMENS MIGHT HAVE BEEN GROSSLY HEMOLYZED SUCH THAT IT AFFECTS THE DENSITY AND THUS THE GEL SEPARATION. · DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? YES. DID EXPOSURE TO BLOOD/ BF OCCUR? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244216 ↗
• MalfunctionJan 25, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT DURING USE WITH BD MICROTAINER® SST¿ 1 OUT OF 24 SAMPLES HAD NO SERUM OBTAINED AFTER CENTRIFUGATION. THE PATIENT WAS RE-COLLECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS THE 3RD OF 5 OCCURRENCES. IT WAS REPORTED BY THE CUSTOMER NO SERUM OBTAINED AFTER CENTRIFUGATION WE TRIED SPINNING USING THE HORIZONTAL SWING BUCKET INSTEAD OF THE FIXED ANGLED, SAME OUTCOME ON 10% OF THE SAMPLES. WE ARE SUSPECTING PERHAPS THESE SPECIMENS MIGHT HAVE BEEN GROSSLY HEMOLYZED SUCH THAT IT AFFECTS THE DENSITY AND THUS THE GEL SEPARATION. DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? YES. DID EXPOSURE TO BLOOD/ BF OCCUR? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244215 ↗
• MalfunctionJan 11, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT AFTER CENTRIFUGATION WITH BD MICROTAINER® SST¿ THERE WAS POOR SEPARATOR MOVEMENT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER AFTER CENTRIFUGING SAMPLES THEY ARE NOT GETTING ANY SERUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141392 ↗
• MalfunctionDec 27, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿ HAD NO SERUM OBTAINED AFTER CENTRIFUGATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER AFTER CENTRIFUGING THEM THEY ARE NOT GETTING ANY SERUM.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056678 ↗
• MalfunctionNov 21, 2022Premature Separation; Premature Separation

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿ TUBE THE BROKEN LID/CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DURING THE BLOOD COLLECTION, CAPS DISLODGED DURING CENTRIFUGATION. CUSTOMER SUSPECTS CAPS WERE NOT SUFFICIENTLY CLOSED. PER DOCUMENT, NO PATIENT ADVERSE EVENT TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838046 ↗
• MalfunctionNov 2, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿, THE DEVICE EXPERIENCED UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED ONCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER PROBLEM: FROM A BD SPONSORED CLINICAL TRIAL, SPECIMEN STOPPED FLOWING INTO TUBE WITH PRODUCT 365967, LOT 1252462. THROUGH A BD SPONSORED CLINICAL TRIAL, PRODUCT CAT NO. 365967, LOT#1252462 HAD UNDERFILL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718272 ↗
• MalfunctionSep 15, 2022Separation Problem; Separation Problem

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿ TUBE THE STOPPER POPPED OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBE DECAPPED DURING THE CENTRIFUGATION PROCESS. LIKELY DUE TO BEING CLOSED INSUFFICIENTLY IN ERROR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15430591 ↗
• MalfunctionNov 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD TUBE MICRO W/MICROGARD SST GLD, THE DEVICE EXPERIENCED POOR SEPARATOR MOVEMENT (SST AND PST ALL TYPES). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE TUBE IS NOT SEPARATING BLOOD PROPERLY. PER EMAIL : HELLO! I AM CURRENTLY A USER OF YOUR MICROTRAINER BRAND TUBES (YELLOW CAP FOR SERUM COLLECTION HTTPS://WWW.BD.COM/EN-US/OFFERINGS/CAPABILITIES/SPECIMEN-COLLECTION/BLOOD-SPECIMEN-COLLECTION/CAPILLARY-COLLECTION/BD-MICROTAINER-BLOOD-COLLECTION-TUBES). RECENTLY WE HAVE BEEN HAVING PROBLEMS WITH THE TUBE NOT SEPARATING THE BLOOD PROPERLY; INSTEAD THE TOP LAYER BECOMES A SOFT GEL AND IS NOT ASPIRATABLE. IT HAPPENS PRETTY RANDOMLY AND WITH ONLY ONE LOT OF TUBES. I JUST WANTED TO CHECK AND SEE IF THERE WAS A RECALL ON THE LOT. LOT NUMBER IS 1055752, WITH EXPIRATION 2022-05-31. THANKS IN ADVANCE FOR YOUR TIME AND HELP!

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888054 ↗
• MalfunctionJul 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DURING A CLINICAL TRIAL CONDUCTED AT THE BABSON DIAGNOSTICS SITE DURING THE WEEK OF (B)(6) 2021, THE CUSTOMER SHARED WITH BD ON (B)(6) 2021, INSTANCES OF ELEVATED LEVELS OF HEMOLYSIS, RESULTING IN FALSELY HIGH POTASSIUM RESULTS, WHEN USING BD MICROTAINER® SST TUBES AS A COMPARATOR DEVICE. IN A FOLLOW-UP DISCUSSION ((B)(6) 2021) WITH THE CUSTOMER, THE CUSTOMER ATTRIBUTED THE ELEVATED LEVELS OF HEMOLYSIS TO A PRE-ANALYTICAL VARIABLE . SUBJECT ID (B)(6) SAMPLE TYPE: VENOUS T07 POTASSIUM: 4.5 SAMPLE TYPE: MICROTAINER T04 POTASSIUM: 6.3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140037 ↗
• MalfunctionJul 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DURING A CLINICAL TRIAL CONDUCTED AT THE BABSON DIAGNOSTICS SITE DURING THE WEEK OF (B)(6) 2021, THE CUSTOMER SHARED WITH BD ON (B)(6) 2021, INSTANCES OF ELEVATED LEVELS OF HEMOLYSIS, RESULTING IN FALSELY HIGH POTASSIUM RESULTS, WHEN USING BD MICROTAINER® SST TUBES AS A COMPARATOR DEVICE. THE CUSTOMER ATTRIBUTED THE ELEVATED LEVELS OF HEMOLYSIS TO A PRE-ANALYTICAL VARIABLE. SUBJECT ID 9A1-001: SAMPLE TYPE: VENOUS T07 POTASSIUM: 4.91. SAMPLE TYPE: MICROTAINER T04 POTASSIUM: 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140033 ↗
• MalfunctionJul 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DURING A CLINICAL TRIAL CONDUCTED AT THE BABSON DIAGNOSTICS SITE DURING THE WEEK OF (B)(6) 2021, THE CUSTOMER SHARED WITH BD ON (B)(6) 2021, INSTANCES OF ELEVATED LEVELS OF HEMOLYSIS, RESULTING IN FALSELY HIGH POTASSIUM RESULTS, WHEN USING BD MICROTAINER® SST TUBES AS A COMPARATOR DEVICE. IN A FOLLOW-UP DISCUSSION (JUNE 11, 2021) WITH THE CUSTOMER, THE CUSTOMER ATTRIBUTED THE ELEVATED LEVELS OF HEMOLYSIS TO A PRE-ANALYTICAL VARIABLE. SUBJECT ID (B)(6); SAMPLE TYPE: VENOUS T07 POTASSIUM: 4.2; SAMPLE TYPE: MICROTAINER T04 POTASSIUM: 8.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139840 ↗
• MalfunctionOct 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE WITH A BD MICROTAINER® SST¿ THE SHIELD WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTS THAT THE SHIELD WAS PARTIALLY DISCOLORED (THE SHIELD PARTIALLY TURNED RED).

  Patient problems: No Patient Involvement

  MAUDE report 10703479 ↗
• MalfunctionJul 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO USE A TUBE WAS DISCOVERED TO BE CRACKED WITH A BD MICROTAINER® SST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: A CRACK ON THE TUBE WAS FOUND BEFORE USE AND THE TUBE WAS THUS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 10240563 ↗
• MalfunctionMay 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE ERRONEOUS SODIUM VALUE RESULTS WITH A BD MICROTAINER® SST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 3 COMPLAINTS) IT IS REPORTED CUSTOMER EXPERIENCED ISSUES WITH SODIUM VALUES COUPLE OF YEARS AGO. BASIC CHEM PANELS WERE RUN ¿ ERRONEOUS NA RESULTS WERE NOTED APPROXIMATELY 1/MONTH FOR A SERIES OF MONTHS DURING THIS TIME. ADDITIONALLY, ON 2020-(B)(6)THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CANNOT CONFIRM THE SPECIFIC LOTS OF THE TUBES THAT YIELDED ERRONEOUS RESULTS. BASIC CHEM PANELS WERE RUN ¿ ERRONEOUS NA RESULTS WERE NOTED APPROXIMATELY 1/MONTH FOR A SERIES OF MONTHS DURING THIS TIME. WILL BE CREATING 2 ADDITIONAL COMPLAINTS FOR THE PRODUCT NUMBERS GIVEN IN CUSTOMERS RESPONSE, AS WELL AS RELATING THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10066174 ↗
• MalfunctionMar 16, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABELS ARE PEELING OFF WITH A BD MICROTAINER® SST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE LABELS HAVE BEEN PEELING OFF FOR THE PAST SIX MONTHS. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: ALL PRODUCTS FEEL ¿SLIPPERY¿. ARE ANY OTHER TUBES AFFECTED? IF YES, PLEASE PROVIDE THE CATALOG REFERENCE AND LOT NUMBER. WE TEST VACUTAINERS, OTHER GLASS AND PLASTIC TUBE TYPES AND NONE ARE DISPLAYING LABELS LIFTING OFF LIKE THE MICROTAINERS ARE. ARE ANY IMAGES AVAILABLE SHOWING THE LIFTING LABELS? NEW LABEL STOCK AND OLD LABEL STOCK RETESTED TO RULE OUT IT BEING A LABEL ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9836572 ↗

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-0060-2020 · May 13, 2019 · Terminated
  BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
• Z-0057-2020 · May 13, 2019 · Terminated
  BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
• 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-0054-2020 · May 13, 2019 · Terminated
  BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
• Z-0058-2020 · May 13, 2019 · Terminated
  BD Microtainer SST- Amber Part/Catalog Number: 365978
• Z-0059-2020 · May 13, 2019 · Terminated
  BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
• Z-1603-05 · Aug 20, 2004 · Terminated
  BD Vacutainer Microtainer Serum tubes (with or without gel).