N/A 340991Recalls & reported problems
Becton, Dickinson And Company · BD® Stem Cell Control · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903409914), received between Dec 13, 2023 and Dec 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT AFTER USING BD STEM CELL CONTROL KIT 15 TESTS IVD ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABNORMALLY HIGH BLOOD CELL COUNT. A NEW LOT OF 340991 WAS MEASURED AND WAS FAR OFF THE MEDIAN VALUE ON THE SPEC SHEET AND DID NOT ENTER THE REFERENCE VALUE. WE TRIED MULTIPLE TIMES WITH DIFFERENT MEASURERS AND EQUIPMENT, BUT THE VALUE REMAINED HIGH. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18321006 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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