N/A 344563Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903445639), received between Aug 10, 2020 and Aug 15, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT AFTER USE OF BD¿ STEM CELL ENUMERATION ERRONEOUS RESULTS WERE ACQUIRED AND PROVIDED TO CLINICIAN. THERE WAS NO IMPACT TO PATIENT AS THE CELL TRANSPLANTATION WAS STILL SUFFICIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER A DETAILED ANALYSIS, IT WAS IDENTIFIED THAT, WHEN COMPARING THE SAME SAMPLES ANALYZED WITH THE NEW KIT (RECENTLY PUT INTO USE) AND WITH THE OLD KIT, THERE WAS A DIFFERENCE OF 30% TO 40% IN CD45+ VALUES. THEREFORE, WE BELIEVE THAT THERE MAY BE A PROBLEM WITH THIS NEW KIT, WHICH AFFECTED THE ACCURACY OF THE TESTS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816971 ↗
• MalfunctionJan 13, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD¿ STEM CELL ENUMERATION WAS MISSING LOT INFO ON THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT 344563_1285770_ MISSING LOT NO ON THE KIT BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252992 ↗
• MalfunctionAug 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT VIABLE CELLS ARE SHOWING UP AS BEING NON-VIABLE WITH A BD¿ STEM CELL ENUMERATION. RESULTS WERE NOT REPORTED OR USED FOR TREATMENT. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CELLS LOOK DEAD WHEN THEY KNOW THEY ARE NOT. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: "CUSTOMER STATED CELLS LOOK DEAD WHEN THEY KNOW THEY ARE NOT." ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. LEAK (IF YES EXPLAIN)? NO. ADDITIONALLY, ON 2020-07-20 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: SPOKE WITH CUSTOMER AFTER THEY SPOKE TO APPS. CUSTOMER IS GOING TO TRY A DIFFERENT BOX OF REAGENTS TO SEE IF THAT MIGHT RESOLVE THE ISSUE. THEY DO NOT HAVE A DIFFERENT LOT OF REAGENT TO TRY JUST A DIFFERENT UNOPENED BOX. CUSTOMER WILL CALLBACK TO LET ME KNOW THE RESULTS OF RUNNING THE NEW BOX OF REAGENTS. CALLED CUSTOMER BACK. RUNNING THE SAMPLES WITH THE OTHER BOX OF REAGENTS YIELDED THE SAME RESULTS. CUSTOMER IS REQUESTING THAT THE FSE COME IN TO CHECK INSTRUMENT. CUSTOMER WILL BE LOOKING TO RUN

  Patient problems: No Patient Involvement

  MAUDE report 10385936 ↗