BD Vacutainer® PST™ Gel and Lithium HeparinN 126 Units 367964Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 30382903679646), received between Dec 5, 2017 and Oct 17, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 reports).

1 FDA recall record name this device's identifier.

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. Jun 12, 2019Class IITerminated

   False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

   Z-2305-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 126 UNITS BLOOD COLLECTION TUBES, THERE ARE HIGH AST RESULTS IN AN UNSPECIFIED NUMBER OF TUBES ACROSS MULTIPLE LOT NUMBERS. LOT NUMBERS WERE NOT PROVIDED. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING THAT THEY HAD CONTINUOUS ISSUE WITH HIGH AST'S IN PST TUBES. WE ARE EXPERIENCING HIGH AST ACROSS ALL LOTS, WE HAVE BEEN HAVING AN ISSUE SINCE SPRING 2022. HOW MANY INDIVIDUALS WERE AFFECTED 20-50 PATIENTS PER DAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952354 ↗
• MalfunctionOct 3, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM "HEPARIN" (LH) 126 UNITS BLOOD COLLECTION TUBES THAT THERE WAS POOR BARRIER SEPARATION OF THE SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES TUBES EXHIBIT RBCS IN THE GEL POST CENTRIFUGATION AND AFTER REFRIGERATION. CUSTOMER STATES SAMPLES ARE DRAWN AND LET SIT AT RT FOR A MINIMUM OF 30 MINUTES BEFORE CENTRIFUGATION. SAMPLES ARE CENTRIFUGED FOR 10 MINUTES AND THEN REFRIGERATED AT 2-8C. WHEN SAMPLES REMOVED FROM THE REFRIGERATOR IT LOOK AS IF THE GEL HAS ABSORBED THE RED CELLS FROM THE BOTTOM OF THE TUBE. CUSTOMER STATES RBCS ARE ABSORBED INTO GEL POST CENTRIFUGATION AND AFTER THEY HAVE BEEN REFRIGERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859874 ↗
• MalfunctionAug 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES CUSTOMER REPORTS AN ELEVATED AST RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT ELEVATED LEVELS AST RESULTS. ELEVATED LEVELS AST RESULTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647295 ↗
• MalfunctionAug 17, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 126 UNITS BLOOD COLLECTION TUBES, THERE IS GEL SMEARING OF 3 TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES GEL CLUMPING POST CENTRIFUGATION AFTER TUBE WAS PLACE IN REFRIGERATOR. GEL LOOKS LIKE IT IS SWELLING AND RBCS ARE BEING ABSORBED INTO GEL. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568817 ↗
• MalfunctionFeb 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE IS DIFFERENCES IN PLASMA AND SERUM VITAMIN B12 RESULTS WITH THE BD TUBE." CUSTOMER WOULD LIKE TO KNOW IF THERE IS ANY SPECIAL HANDING WITH BD TUBES AND VITAMIN B12. THEY STARTED TROUBLE SHOOTING (B)(6) 2020, THERE IS NO SPECIFIC LOT NUMBER ASSOCIATED WITH THE ON (B)(6) 2021: EMAIL - THE VB12 RESULTS DECREASE TO CLINICAL EXPECTATION AFTER TUBES SIT UPRIGHT (~30 MIN) OR ARE RE CENTRIFUGED. PLASMA IS NOT AS CLEAN A SPECIMEN AS SERUM; CELLULAR MATERIAL REMAINS IN THE PLASMA ABOVE THE GEL, AND MAY BE RE-SUSPENDED IF PST TUBES ARE PLACED ON THEIR SIDES OR TRANSPORTED; THESE MAY AFFECT RESULTS WHEN ANALYTES ARE BEING MEASURED IN THE PG/ML RANGE. WE DO NOT RECOMMEND RE-CENTRIFUGATION.

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

  MAUDE report 11334315 ↗
• MalfunctionJan 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 126 UNITS BLOOD COLLECTION TUBES ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE LOT YIELDS BAD RESULTS.

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

  MAUDE report 11233522 ↗
• MalfunctionJan 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED THAT THERE ARE ERRONEOUS RESULTS. SO WE ORDER ITEM NUMBER 02-687-104 BLOOD TUBE PST AND ONE OF MY LAB SCIENTIST CAME ACROSS A PROBLEM WITH A SPECIFIC LOT NUMBER OF THESE TUBES WHICH IS 0100300 AND WE HAVE 9 PACKS OF THESE TUBES WITH THIS LOT NUMBER. SOMETHING IS WRONG WITH THE TUBES AND THE LAB RESULTS ARE COMING UP INSANELY WRONG WHEN THESE SPECIFIC LOT NUMBER OF TUBES ARE BEING TESTED.

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

  MAUDE report 11120479 ↗
• MalfunctionDec 15, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "LAB MANAGER CALLED INTO SEE IF ANYONE HAS REPORTED EXPERIENCING ERRONEOUS RESULTS WITH PRODUCT 367964, LOT 0100300. SHE HAS EXPERIENCED POTASSIUM LEVELS GREATER THAN 10 AND CALCIUM LEVELS LESS THAN ONE. NO SAMPLES ARE AVAILABLE. UNSURE OF MEDICAL INTERVENTION. 23-NOV-2020: "CUSTOMER STATES IT HAPPENED 6 TIMES WITH DIFFERENT PHLEBOTOMISTS ON DIFFERENT FLOORS. SHE STATES THE ORDER OF DRAW IS CORRECT, AND WHEN THE PATIENT IS RE-DRAWN, THE K AND CA ARE NORMAL. I INFORMED HER THAT IF THE CONTENTS OF THE EDTA TUBE ARE POURED INTO THE PST TUBE, YOU CAN SEE THESE ERRONEOUS RESULTS. SHE STATED THAT HER PHLEBOTOMISTS DID NOT DO THIS." 24-NOV-2020: CUSTOMER RESPONSE, - "NO ERRONEOUS RESULTS. CONDITION OF SAMPLE IS GOOD. ORDER OF DRAW: CONFIRMED ON AT LEAST ONE PATIENT THAT THE LAVENDER DRAWN LAST. UNKNOWN ON THE REST. SPECIMENS WERE LEFT 10-20 MINS BEFORE CENTRIFUGATION. A SWING BUCKET WAS USED. POTASSIUM WAS RUN. NORMAL RANGES OF POTASSIUM ARE 3.5-5.1. PATIE

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

  MAUDE report 11006106 ↗
• MalfunctionDec 2, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE RUBBER STOPPER REMAINED IN THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE DURING R&D TESTING FOR STOPPER REMOVAL FORCES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING, WE OBSERVED SOME TUBES WITH 2ND TIME STOPPER REMOVAL FORCES THAT DID NOT MEET THE MINIMUM AND/OR MEAN FORCE SPECIFICATION. THE PRODUCT INFORMATION IS LISTED BELOW. CATALOG # BATCH # TEST DATE DATA REVIEW DATE OBSERVATION 367964 9095794 (B)(6)2019 (B)(6)2019 DID NOT MEET MINIMUM FORCE SPECIFICATION 367729 9241023 (B)(6)2019 (B)(6)2019 DID NOT MEET MEAN FORCE SPECIFICATION 367729 9241024 (B)(6)2019 (B)(6)2019 DID NOT MEET MEAN FORCE SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9396783 ↗
• MalfunctionNov 22, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MATERIAL NO. 367964 BATCH NO. 9065839. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 126 UNITS BLOOD COLLECTION TUBES THERE WAS RBC SEEPAGE PAST THE GEL BARRIER AFTER CENTRIFUGATION. THIS OCCURRED ON (B)(4) SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING IN FRANKLIN LAKES, WE OBSERVED RBC SEEPAGE PAST THE GEL BARRIER AFTER CENTRIFUGATION IN THE FOLLOWING BD VACUTAINER® PST¿ TUBE. THE PRODUCT INFORMATION IS BELOW. CATALOG #: 367964. BATCH #: 9065839. TEST DATE: (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9363472 ↗
• MalfunctionOct 21, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 126 UNITS BLOOD COLLECTION TUBE EXPERIENCED MISSING COMPONENT OF PRODUCT WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367964. BATCH NO. 9095794. PER EMAIL: DURING R&D TESTING, ONE TUBE WAS FOUND IN THE SHELF PACK THAT DID NOT HAVE A STOPPER. THE PRODUCT INFORMATION IS: CATALOG # - 367964, BATCH # - 9095794, TEST DATE ¿ 4 OCT 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9213907 ↗
• MalfunctionJul 31, 2019Leak/Splash; Leak/Splash

  IT HAS BEEN REPORTED THAT ONE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 126 UNITS BLOOD COLLECTION TUBE HAS BEEN FOUND WITH THE STOPPER COMING OUT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE TUBES FAILED A 2ND STOPPER PULLOUT FORCE THAT WAS JUST BELOW THE MINIMUM SPECIFICATION. DURING R&D TESTING IN FRANKLIN LAKES, WE HAD A 2ND STOPPER PULLOUT FORCE THAT WAS JUST BELOW THE MINIMUM SPECIFICATION. CATALOG NUMBER: 367964, BATCH NUMBER: 9095793, TEST DATE: (B)(6) 2019 AND DATA REVIEW DATE: 19 JULY 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8847774 ↗
• MalfunctionSep 27, 2018Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES UNDER FILLED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7914844 ↗
• MalfunctionJun 7, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 126 UNITS BLOOD COLLECTION TUBES HAD ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7580917 ↗
• MalfunctionJun 4, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD HAD HEMOLYSIS SAMPLE QUALITY. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7567504 ↗
• MalfunctionMay 22, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 126 UNITS BLOOD COLLECTION TUBES EXPERIENCED POOR SEPARATION. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7535044 ↗
• MalfunctionMay 10, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES HAD CLOUDY SERUM AND PLASMA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503408 ↗
• MalfunctionMay 9, 2018Leak/Splash; Delivered as Unsterile Product; Leak/Splash; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES HAD TUBE CAPS THAT WERE NOT FULLY CLOSED AND HAD A CAP MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7500693 ↗
• MalfunctionMay 3, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 126 UNITS BLOOD COLLECTION TUBES HAD POOR GEL MIGRATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7485014 ↗
• MalfunctionDec 5, 2017Detachment Of Device Component; Compatibility Problem

  IT WAS REPORTED THAT A PLASTIC PST TUBE FOR PLASMA SEPARATION LITHIUM HEPARIN 8.0 ML DRAW, 16X100MM CAPS KEPT FALLING OFF. THE CAPS WERE REPORTED TO BE TOO SMALL AND THE TUBES DID NOT VACUUM. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7083343 ↗