BD 663028Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382906630285), received between May 24, 2022 and Dec 15, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 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-0172-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD TRUCOUNT¿ TUBES, ERRONEOUS FINAL LABORATORY RESULT FROM THE BD PRODUCT WERE REPORTED TO A CLINICIAN. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIABLE COUNTING OF BEADS IN THE TRUCOUNT TUBE IT WAS REPORTED THAT QUANTIFICATION OF LYMPHOCYTES, COUNTED ON FACS LYRIC FOR 5 MINUTES. WE EXPECTED ABOUT 20,000 BEADS BUT GOT 81,000 BEADS¿FOUR TIMES TOO MANY BEADS. THE SAMPLE WAS SET UP AGAIN, AND THE RESULT WAS AS EXPECTED (SEE ATTACHED FILE ON ATG PATIENT FROM JULY 13). THIS WAS DISCOVERED IN A SAMPLE THAT WAS SET UP TO BE COUNTED FOR 5 MINUTES, WHICH MADE IT EASIER TO DETECT SINCE THE BEAD COUNT WAS SO HIGH. HOWEVER, WE HAVE SEEN THIS PROBLEM A COUPLE OF TIMES BEFORE. ONE OF THESE WAS DISCOVERED WHEN THE REQUESTER CALLED AND QUESTIONED THE RESULTS WE HAD ISSUED; THEY WERE LOWER THAN WHAT THE REQUESTER EXPECTED. UPON REANALYSIS, THE ANSWER WAS MORE AS EXPECTED, AND IT TURNED OUT THERE WERE TOO MANY BEADS IN THE FIRST RUN (SEE ATTACHED PLOT FROM JUNE 3). THERE IS A SIGNIFICANT UNCERTAINTY HERE REGARDING HOW OFTEN THIS MAY HAVE HAPPENED WITHOUT BEING DETECTED. IT¿S NOT LIKE WE ALWAYS HAVE PREVIOUS TEST R

  Patient problems: Insufficient Information

  MAUDE report 23804800 ↗
• MalfunctionDec 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD TRUCOUNT¿ TUBES, ERRONEOUS FINAL LABORATORY RESULT FROM THE BD PRODUCT WERE REPORTED TO A CLINICIAN. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIABLE COUNTING OF BEADS IN THE TRUCOUNT TUBE. IT WAS REPORTED THAT QUANTIFICATION OF LYMPHOCYTES, COUNTED ON FACS LYRIC FOR 5 MINUTES. WE EXPECTED ABOUT 20,000 BEADS BUT GOT 81,000 BEADS¿FOUR TIMES TOO MANY BEADS. THE SAMPLE WAS SET UP AGAIN, AND THE RESULT WAS AS EXPECTED. THIS WAS DISCOVERED IN A SAMPLE THAT WAS SET UP TO BE COUNTED FOR 5 MINUTES, WHICH MADE IT EASIER TO DETECT SINCE THE BEAD COUNT WAS SO HIGH. HOWEVER, WE HAVE SEEN THIS PROBLEM A COUPLE OF TIMES BEFORE. ONE OF THESE WAS DISCOVERED WHEN THE REQUESTER CALLED AND QUESTIONED THE RESULTS WE HAD ISSUED; THEY WERE LOWER THAN WHAT THE REQUESTER EXPECTED. UPON REANALYSIS, THE ANSWER WAS MORE AS EXPECTED, AND IT TURNED OUT THERE WERE TOO MANY BEADS IN THE FIRST RUN. THERE IS A SIGNIFICANT UNCERTAINTY HERE REGARDING HOW OFTEN THIS MAY HAVE HAPPENED WITHOUT BEING DETECTED. IT¿S NOT LIKE WE ALWAYS HAVE PREVIOUS TEST RESULTS TO COMPARE WITH. WHEN DID THE INCIDENT OCCUR? - DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 23804402 ↗
• MalfunctionDec 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES AN OVER ESTIMATION OF ABSOLUTE COUNTS WAS EXPERIENCED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "PROBLEM ENCOUNTERED WITH PATIENT SAMPLES: EXCESSIVE DEVIATION OF THE ABSOLUTE VALUE OF LYMPHOCYTES CALCULATED WITH TRUCOUNT TUBES COMPARED WITH CBC LYMPHOCYTES, COMPARED WITH THE DEVIATION VALUES DEFINED BY THE LABORATORY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20994083 ↗
• MalfunctionDec 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES AN OVER ESTIMATION OF ABSOLUTE COUNTS WAS EXPERIENCED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "PROBLEM ENCOUNTERED WITH PATIENT SAMPLES: EXCESSIVE DEVIATION OF THE ABSOLUTE VALUE OF LYMPHOCYTES CALCULATED WITH TRUCOUNT TUBES COMPARED WITH CBC LYMPHOCYTES, COMPARED WITH THE DEVIATION VALUES DEFINED BY THE LABORATORY.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20993611 ↗
• MalfunctionMar 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USING BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS WERE AQUIRED. NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER OBSERVE SURRESTIMATION OF ABSOLUTE COUNTING ON ITS BD FACSLYRIC ON FACSUITE CLINICAL SOFTWARE AS COMPARED WITH NUMERATION ON ITS SYSMEX HEMATOCYTOMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871226 ↗
• MalfunctionNov 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES WAS UNABLE TO DISPLAY ALL KNOWN TRUCOUNT BEADS DURING IVD TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOR HALF OF SAMPLES INSUFFICIENT BEAD NUMBER WAS ACQUIRED FOR THE TRUCOUNT BEADS LOT 22103. THIS WAS OBSERVED ON FACSCANTOII AND FACSCALIBUR INSTRUMENTS. NO PROBLEM DETECTED ONCE ANOTHER BEAD LOT WAS USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242935 ↗
• MalfunctionSep 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD TRUCOUNT¿ TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. IF THERE WAS ANY CONTAMINATION THAT INVOLVES PATIENT SAMPLE? NO. 2. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES. 3. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? NO. LEUCOCYTE COUNTS WITH LOT 3186043 ARE TOO HIGH AND DEVIATE FROM HEMATO ANALYZER WITH 25% WHEN DID THE INCIDENT OCCUR? DURING USE DETAILED INCIDENT DESCRIPTION LEUCOCYTE COUNTS WITH LOT 3186043 ARE HIGHER COMPARED TO COUNTS FROM SAME SAMPLE WITH HEMATO ANALYZER. DEVIATION WITH 25% FOR BOTH PATIENT SAMPLES AND CONTROL MATERIAL. WITH MULTIPLE PREPARATIONS, BY MULTIPLE TECHNICIANS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839452 ↗
• MalfunctionJun 27, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD TRUCOUNT¿ ABSOLUTE COUNTING TUBE HAS BEEN FOUND PRODUCING ERRONEOUS RESULTS. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS AN INCREASED FREQUENCY OF DISCORDANCE BETWEEN ABSOLUTE VALUE OF TOTAL LYMPHOCYTES OBTAINED BY CYTOMETRY, AND THE BLOOD COUNTING RESULTS FROM SYSMEX (OR EQUIVALENT). SOMETIMES THE DIFFERENCE BETWEEN THOSE TWO VALUES REACHES > 20 OR EVEN >30% IN EXCESS. THE CUSTOMER USES BD FACSDUET AND LYRIC WITH QC THAT ARE "PASS". NO TECHNICAL ISSUE FROM AN INSTRUMENT PERSPECTIVE. HOWEVER THEY CHANGED RECENTLY FROM THEIR FORMER TRUCOUNT TUBE AND USE NOW THE TRUCOUNT LOT (21280). THE INCREASE OF DISCORDANCE MATCHES WITH THE USE OF THIS NEW LOT. THIS LOT HAS BEEN ALREADY REPORTED TO BE ASSOCIATED WITH THE SAME PHENOMENON IN DIFFERENT LABS. IMPACT : THESE TRUCOUNT TUBE ALLOW THE NUMERATION OF LEUKOCYTE POPULATION IN CYTOMETRY. ANY INCORRECT ABSOLUTE VALUE OBTAINED BY CYTOMETRY IN THE NUMERATION ON LYMPHOCYTES AND THEIR ASSOCIATED POPULATIONS IN BLOOD MAY IMPAIR ACCURACY OF THE DIAGNOSTIC. CUSTOMER ASK US TO QUICKLY REPLACE THEIR CURRENT LOT BY A NEW LOT. ¿ WERE PATIENT SAMPLES INVOLVED? YES ¿ WAS IT OBVIOUS THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14832134 ↗
• MalfunctionMay 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD TRUCOUNT¿ TUBES ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCREPANCY BETWEEN COUNTS DONE WITH TRUCOUNT TUBES LOT 1348535 AND 2 OTHER LOTS CUSTOMER COMPARED COUNTING WITH LOT 1348535 TO 2 OTHER LOTS OF TRUCOUNT TUBES. COUNTING WITH LOT 1348535 GIVES DIFFERENT RESULTS THAN 2 OTHER LOTS AND CELLULAR COUNTER. OTHER REAGENTS USED ARE THE SAME. LOTS ARE TESTED IN PARALLEL ON SAME SAMPLE. PLEASE FIND THE ANSWERS OF THE CUSTOMER BELOW: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4) NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO. 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6) N/A. 6. WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.) N/A".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548941 ↗
• MalfunctionMay 24, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD TRUCOUNT¿ TUBES PRODUCED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORT A DEFECTIVE TRUCOUNT LOT (21280). THESE TRUCOUNT TUBE ALLOW THE NUMERATION OF LEUKOCYTE POPULATION IN CYTOMETRY. THIS DEFECTIVE LOT LEADS TO BIAS IN THE NUMERATION OF LEUKOCYTE POPULATION IN BLOOD AND IN BONE MARROW, WHICH COULD IMPAIR THE ACCURACY OF THE DIAGNOSTIC. THEY ASK US TO QUICKLY REPLACE THEIR CURRENT DEFECTIVE LOT BY A NEW LOT (IDEALLY 22020). THE BIAS IN THE NUMERATION COULD IMPACT THE DIAGNOSTIC. PLEASE FIND ANSWERS BELOW: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) - YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) - THERE WAS FOR SURE A DELAY IN THE DIAGNOSIS, BUT I AM NOT SURE THAT THIS WAS RESPONSIBLE FOR A DELAY IN THE TREATMENT, SINCE THE CUSTOMER IS COMPETENT AND SINCE SHE CALLED US AS SOON AS THE ISSUE WAS CHARACTERIZED. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4) - I DON¿T KNOW. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489985 ↗