N/A 340922Recalls & reported problems
Becton, Dickinson And Company · BD® CD10 (HI10a) APC · Class 1
Data updated Oct 16, 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 00382903409228), received between Apr 4, 2024 and Apr 4, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.
MalfunctionApr 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING CD10 (HI10A) APC ERRONEOUS RESULTS WERE OBTAINED. ERRONEOUS RESULTS WERE REPORTED, HOWEVER, THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE STAINING OF CD10 APC (340922_3087869) ON B CELLS BY SOFTWARE HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS ERRONEOUS REPORTING OF CD10+ FOLLICULAR LYMPHOMA ON A PATIENT SAMPLE THAT IHC IDENTIFIED AS CD10- MANTLE CELL LYMPHOMA. CLINICAL FAS OPTIMIZED SETTINGS FOR V450 AND ADDED SOME LABEL SPECIFIC SPILLOVER CONTROLS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19047377 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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