BD Vacutainer® SST™ 367987Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 30382903679875), received between Nov 29, 2017 and Feb 10, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (31 reports).

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

2 other recalls cover devices cleared under the same FDA submission (BK050036); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 25, 2022Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Material Deformation

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE STOPPER WAS COCKED IN TWO (2) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307421 ↗
• MalfunctionAug 1, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS NO VACUUM ON PRODUCT: 367987, LOT: 1333107."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141444 ↗
• MalfunctionFeb 3, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE USER IDENTIFIED USING THE TUBE AFTER THE RECOMMENDED EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER USED 367988 AND 367987 AFTER EXPIRATION AND ARE WONDERING WHAT THE IMPACT IS ON THEIR SAMPLES. EXP 12/31 AND THEY USED AT LEAST 25 UNTIL THEY REALIZED THEY WERE EXPIRED ON THE 14TH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446650 ↗
• MalfunctionOct 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT THEY STARTED "TO SEE VARIABILITY IN SOME OF THE CLINICAL CHEMISTRY AFTER SWITCHING TO MATERIAL 367987 FROM MATERIAL 367986."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674585 ↗
• MalfunctionSep 20, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT IS REPORTED CUSTOMER IS EXPERIENCING UNDER FILLING. TIGER TOP SST 7.5ML, MANY OF THE TUBES DO NOT HAVE A VACUUM IN THEM, SEEMS TO BE RANDOM IN THAT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502292 ↗
• MalfunctionFeb 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS HEMOLYSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE BEEN EXPERIENCING HEMOLYSIS FOR THE PAST COUPLE OF MONTHS. NO SPECIFIC DATE OF EVENT, NO AMOUNT OF OCCURRENCES, NO BATCH NUMBER, NO SAMPLES AVAILABLE, NO PHOTOS AVAILABLE, NO MEDICAL INTERVENTION, NO ERRONEOUS RESULTS. CUSTOMER DOESN'T REQUIRE ACKNOWLEDGEMENT NOR CLOSURE LETTER AS HE IS ONLY REQUESTING TECH SERVICES.". 2/1/2021 SPOKE WITH THE CUSTOMER AND REVIEWED TOURNIQUET USE AND PROCESSING. CUSTOMER STATED THE TUBES ARE UNSPUN AND SENT FROM (B)(6) ON ICE, ABOUT 24 HOURS IN TRANSPORT TIME. TEACHING PROVIDED REGARDING THAT CENTRIFUGE WITHIN 2 HOURS OF COLLECTION AND THEN TRANSPORTED AT RT CONDITIONS, TUBES IN CONTACT WITH THE ICE WILL CAUSE LYSIS THE CELLS AND HEMOLYSIS MAY "OCCUR". IFU AND THE TROUBLESHOOTING HEMOLYSIS CHART WAS PROVIDED.

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

  MAUDE report 11362369 ↗
• MalfunctionMay 20, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN EXPIRED TUBE WAS USED WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER USED AN EXPIRED TUBE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10075680 ↗
• MalfunctionMar 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USE THERE WAS POOR BARRIER SEPARATION WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED THAT CUSTOMER EXPERIENCED POOR BARRIER SEPARATION. ADDITIONALLY, ON 2020-03-03 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: EXPLAINED THAT IF THERE WAS ONLY ONE TUBE WITH POOR SEPARATION, IT COULD BE RELATED TO THE PATIENT CONDITION. OTHER FACTORS COULD BE NOT INVERTING THE TUBE, THE CENTRIFUGE SPEED AND TIME, AND CLOTTING TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9865485 ↗
• MalfunctionAug 7, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT LOW DRAW OCCURRED DURING USE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ALL TUBES WOULD FILL SLOWLY AND THEN QUIT FILLING LIKE NOT ENOUGH VACUUM. MY BLOOD DRAW FOLKS HAVE REPORTED THAT THEY HAVE HAD SOME ISSUES FILLING THE SSTS (7.5ML). NOT A CONSISTENT PROBLEM ¿ ABOUT 3 IN THE LAST 37 BLOOD DRAWS. ARE THERE ANY NOTICES/ALERTS/RECALLS WITH REF 367987; LOT 9029645?" 2 OCCURRENCES WERE REPORTED TO HAVE OCCURRED ON 06/27/2019. 1 OF 2 COMPLAINTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8871548 ↗
• MalfunctionJul 15, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  (B)(4). IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THERE WERE FILLING ISSUES WITH THE TUBES. THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY BLOOD DRAW FOLKS HAVE REPORTED THAT THEY HAVE HAD SOME ISSUES FILLING THE SSTS (7.5ML). NOT A CONSISTENT PROBLEM ¿ ABOUT 3 IN THE LAST 37 BLOOD DRAWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8791634 ↗
• MalfunctionMay 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367987, BATCH NO. 8292805. IT WAS REPORTED THERE WERE "SPURIOUS RESULTS." (11 OF 26). EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569281 ↗
• MalfunctionMay 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367987, BATCH NO. 8292805. IT WAS REPORTED THERE WERE "SPURIOUS RESULTS. (20 OF 26). EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569171 ↗
• MalfunctionMay 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367987, BATCH NO. 8292805. IT WAS REPORTED THERE WERE "SPURIOUS RESULTS." (12 OF 26). EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES.

  Patient problems: Test Result

  MAUDE report 8569169 ↗
• MalfunctionApr 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO. 367987, BATCH NO. 8292805. IT WAS REPORTED THERE WERE "SPURIOUS RESULTS." (9 OF 26). EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8567096 ↗
• MalfunctionApr 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO. 367987, BATCH NO. 8292805. IT WAS REPORTED THERE WERE "SPURIOUS RESULTS." (16 OF 26). EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8567074 ↗
• MalfunctionApr 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO. 367987 BATCH NO. 8292805 IT WAS REPORTED THERE WERE "SPURIOUS RESULTS." (15 OF 26) EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8567059 ↗
• MalfunctionApr 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO. 367987, BATCH NO. 8292805. IT WAS REPORTED THERE WERE "SPURIOUS RESULTS." (25 OF 26). EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8567038 ↗
• MalfunctionApr 29, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367987, BATCH NO. 8292805. (19 OF 26). EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8561752 ↗
• MalfunctionApr 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367987, BATCH NO. 8292805 (24OF 26). EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8557228 ↗
• MalfunctionApr 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367987, BATCH NO. 8292805. (13 OF 26). EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8556979 ↗
• MalfunctionApr 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367987, BATCH NO. 8292805, (7 OF 26). EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8556699 ↗
• MalfunctionApr 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THERE WERE "SPURIOUS RESULTS." EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552527 ↗
• MalfunctionApr 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THERE WERE "SPURIOUS RESULTS." EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES.

  Patient problems: Test Result

  MAUDE report 8552522 ↗
• MalfunctionApr 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS ERRONEOUS RESULTS WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THERE WERE "SPURIOUS RESULTS." (EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552503 ↗
• MalfunctionApr 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS ERRONEOUS RESULTS WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXPERIENCING A FEW SPURIOUS RESULTS ON DIFFERENT CHEMISTRY ANALYTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552433 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under BK050036. One submission often covers many models, so check the product and lot details in each record.

• Z-0968-2018 · Aug 29, 2017 · Terminated
  BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing an
• Z-2434-2015 · Jun 23, 2015 · Terminated
  BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.