BD Trucount 340334Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903403349), received between Aug 24, 2020 and May 2, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 reports).

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

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. Oct 3, 2022Open, Classified

   Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.

   Z-0171-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS WERE OBSERVED AND REPORTED TO A CLINICIAN. THE NUMBER OF PATIENTS AFFECTED COULD NOT BE CONFIRMED AND NO SERIOUS INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CD45 ABSOLUTE COUNT FOR THE 3 TUBES FOR THE PIP DOES NOT MATCH THUS THE ABSOLUTE COUNTS FOR THE LYMPHOCYTE MARKERS ARE INACCURATE. IT AFFECTED MANY RESULTS THAT WE HAVE TO REPEAT AND POSSIBLE OTHER RESULTS THAT WE HAVE ALREADY REPORTED THAT WE CAN NO LONGER REPEAT DUE TO SAMPLE STABILITY. WE DON'T KNOW IF THERE ARE SINGLE-TUBE ASSAY THAT WE REPORTED INCORRECTLY, LIKE I MENTIONED EARLIER IT WOULD BE HARD TO CATCH IT IN A SINGLE-TUBE ASSAY AND WE HAVE NOT RECEIVED ANY CALLS FROM OUR CLIENTS, YET. SO, WE DON'T KNOW THE ANSWER TO THE FOLLOWING QUESTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955283 ↗
• MalfunctionMay 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS WERE OBTAINED AND REPORTED TO CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DIFFERENCES APPEARED IN ABSOLUTE VALUES BETWEEN TWO CYCLOMETERS ON THE SAME SAMPLE ID THE CUSTOMER SAID SHE IS OBLIGED TO INITIATE AN OFFICIAL COMPLAINT TO HEALTH AUTHORITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351988 ↗
• MalfunctionNov 27, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABNORMAL HIGH RESULTS WITH LOT 23128. WHEN DID THE INCIDENT OCCUR? DURING USE. TRUCOUNT TUBES GIVE EITHER NORMAL OR HIGHER RESULTS, UP TO +25%. WE HAVE VERIFIED THE TRUCOUNT ABORT TO ELIMINATE A PROBLEM OF UNDERCOUNTING OF BEADS BY ABORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208860 ↗
• MalfunctionJun 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD TRUCOUNT¿ TUBES THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADDITIONAL INFORMATION RECEIVED ON JUN-02-2023 FROM THE CUSTOMER: "REGARDING WHAT HAPPENED WITH THE BOX OF BD TRUCOUNT TUBES, I INFORM YOU THAT TWO DAYS AFTER THE BOX OF TRUCOUNT TUBES ENTERED, IT WAS ON APRIL 27 WHEN I REALIZED THE RESULTS OF A RUN OF 11 PATIENTS THAT DID NOT CORROBORATE WITH THEIR CD4/CD8 HISTORIES, THEY BEGAN TO REVIEW THE INSTRUMENT, THE REAGENT, THE PIPETTES AND THE TRUCOUNT TUBES, NOTICING THAT 15 TUBES HAD DEHYDRATED BEADS, DR. T.V. WAS INFORMED ON APRIL 28. SHE THEN SENT HIM THE REQUESTED DATA ACCORDING TO THE QUESTIONS: APPLICATIONS SPECIALIST WAS ACCOMPANYING THE USER IN THE CREATION OF REFERENCE SETTINGS OF THE FACS LYRIC EQUIPMENT. THE USER MENTIONED THAT SHE HAD REMEMBERED THAT THEY DETECTED DEFECTIVE TRU COUNT TUBES. HE TOOK 15 TRU COUNT TUBES WITH THE DEHYDRATED BEADS FROM A BAG THAT WAS SEPARATED AND REFRIGERATED. LOT: 22046, EXPIRATION DATE FEBRUARY 29, 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243394 ↗
• MalfunctionApr 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD TRUCOUNT¿ TUBES THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, SUBPOPULATIONS ARE SEEN IN ADDITION TO THE BEAD BODY POPULATION WHEN MEASURING BEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663474 ↗
• MalfunctionNov 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD TRUCOUNT¿ TUBES THAT THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LABORATORY REPORTS TO CLINICAL SPECIALIST (B)(6). ON THURSDAY, OCTOBER 13 AT 4:54 P.M. VIA EMAIL, WHICH THE USER (B)(6) FOUND INSIDE A NEW BAG OF TRUCOUNT TUBES INCLUDED IN THE MULTITEST KIT (CATALOG 340491) AT THE TIME OF ASSEMBLING THE MULTITEST FOR T LYMPHOCYTES WITH PATIENT SAMPLES ON (B)(6) 2022. , LOT 2152075, WITH EXPIRATION DATE 31 MAR 2024), SEVEN (7) TUBES WITH THE LYOPHILIZED PEARLS AT THE BOTTOM OF THE TUBE VISIBLY SMALLER THAN USUAL. EVEN IN SOME TUBES, THE PEARL PELLET WAS OBSERVED OUTSIDE THE METAL GRID THAT CONTAINS THEM. UNDER NORMAL CONDITIONS AND ACCORDING TO WHAT IS TAUGHT BY OUR CLINICAL SPECIALISTS IN THE TRAINING GIVEN, THESE TUBES SHOULD NOT BE USED TO CARRY OUT THE TEST. HOWEVER, THE USER EXPLAINS THAT THE TUBES WERE USED BECAUSE THEY DID NOT HAVE UNITS AVAILABLE IN THE LABORATORY DUE TO A DELAY IN THE ARRIVAL OF THE ORDER AND DUE TO THE NEED TO ASSEMBLE THE SAMPLES THAT DAY. OF THE 7 TUBES, TWO SAMPLES HAD TO BE REPEATED LATER BECAUSE BEADS WERE NOT OBSERVED IN THE PLOTS DISPLAYED IN THE BD FACSCANTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756111 ↗
• MalfunctionAug 26, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE LABEL WAS MISSING ON THE TUBE WITH A BD TRUCOUNT¿ TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LABEL ON THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370135 ↗
• MalfunctionJul 15, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD TRUCOUNT¿ TUBES THERE WERE DIFFERING RESULTS WHEN USING 2 DIFFERENT INSTRUMENTS. THIS OCCURRED ON 2 OCCASIONS, HOWEVER, THERE WAS NO SPECIFIC IMPACT TO PATIENT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE CUSTOMER SYSTEMATICALLY OBSERVE A 20% BIAS OF ABSOLUTE NUMBER OF CELLS CALCULATED USING TRUCOUNT TUBES ON FACSLYRIC CYTOMETER OR USING SYSMEX CYTOMETER. THIS IS NOT DEPENDENT ON THE TRUCOUNT LOT. THE SAME TUBE IS ANALYSED APPROXIMATELY AT THE SAME TIME ON THE 2 INSTRUMENTS. I HAVE CHECKED MYSELF THAT IS WAS NOT DUE TO A BAD GATING POSITIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174785 ↗
• MalfunctionJul 13, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LOT # ON 12 BAGS IS DIFFERENT THAN THE LOT # ON THE SHIPPER WITH A BD TRUCOUNT¿ TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE BATCH OF THE PRODUCT PACKAGING BOX DOES NOT MATCH THE BATCH OF THE INNER BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160563 ↗
• MalfunctionJun 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING WITH BD TRUCOUNT¿ TUBES ERRONEOUS RESULTS WERE OBTAINED WITH 9 PATIENT SAMPLES. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: PEARL MEASUREMENT PROBLEMS. YESTERDAY THE CLIENT TELLS US THAT HE CONTINUES WITH THE SAME PROBLEM OF 40 SAMPLES, 9 HAD TO BE REPEATED SINCE THE RESULTS DID NOT CORRESPOND WITH THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037978 ↗
• MalfunctionAug 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES THE RESULTS OF ABSOLUTE COUNTS ARE ABNORMAL. THERE WAS NO DELAY IN TREATMENT OR IMPACT TO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN OPEN THE PACKAGE, THE DESICCANT IS NORMAL, BUT THE PELLET WAS ABNORMAL SHRINKAGE AND ABOVE THE MESH. DUE TO THIS ISSUE, THE RESULTS OF ABSOLUTE COUNTS ARE ABNORMAL. ADDITIONALLY, ON 2020-08-04 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES, ONLY A FEW MINUTES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. REDRAWN. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10442619 ↗