BD Kiestra™ IdentifA 444063Recalls & reported problems
Becton, Dickinson And Company · BD Kiestra™ IdentifA · Class 2
Data updated Oct 18, 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 00382904440633), received between Dec 9, 2024 and Dec 9, 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 18, 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 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT FOUR SPECIMENS THAT WERE PREPARED ON THE BD KIESTRA¿ IDENTIFA GAVE FALSE IDENTIFICATION RESULTS: ENTEROCOCCI WAS IDENTIFIED AS STAPHYLOCOCCUS ENTEROCOCCI WAS IDENTIFIED AS ECOLI PROTEUS WAS IDENTIFIED AS STAPH. HEMOLYTICUS E. COLI WAS IDENTIFIED AS STR. CONSTELLATUS THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20887263 ↗
Other Mass spectrometry, MALDI TOF, microorganism identification, cultured isolates devices
- VITEK® MS PRIME 423281Biomerieux SA · Mass spectrometry, MALDI TOF, microorganism identification, cultured isolates35 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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