BD Kiestra™ ReadA™ Compact 447206Recalls & reported problems
BD Kiestra B.V. · BD Kiestra™ ReadA™ Compact · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382904472061), received between Apr 16, 2023 and Jun 17, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT HAS BEEN REPORTED THAT THE BD KIESTRA READA COMPACT HAS BEEN FOUND CONTRIBUTING TO ERRONEOUS PATIENT RESULTS. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22243466 ↗MalfunctionApr 16, 2023Contamination; Contamination
IT WAS REPORTED THAT WHILE USING THE BD KIESTRA READA COMPACT THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ DURING THE READING CUSTOMER FOUND THAT THERE IS 3 DISHES THAT HAS MOLD ON IT . ¿ CUSTOMER GAVE THE DISHES NUMBER TO PROCEED TO FIND ALL THE LOCATIONS THAT WERE ON THE RC. ¿ CUSTOMER PROCEED TO DECONTAMINATE ALL THE AREAS WHEN THIS DISHES WERE. ¿ CUSTOMER IS ALSO COMPLAINING THAT THIS RC3 HAS A LOT HUMIDITY AND BAD SMELL. ¿ CUSTOMER IS ASKING FROM COMPLETE CHECK OF THIS RC AND ASKING DECONTAMINATION PROCEDURE. ¿ FOR NOW CUSTOMER WILL CHECK PLATE BY PLATE TO ENSURE THAT THERE IS NO MOLD ON IT. R 2. ISSUE DESCRIPTION: CUSTOMER REPORTS THAT FIND MOLD IN THE RC3 IN 3 DISHES IN RC3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16748648 ↗
Other BATH, INCUBATORS/WATER, ALL devices
- BD Kiestra™ ReadA 446948BD Kiestra B.V. · BATH, INCUBATORS/WATER, ALL1 recall0 reports
- NA 05.725.010Synthes GmbH · BATH, INCUBATORS/WATER, ALL4 reports
- NA 530.510Synthes GmbH · BATH, INCUBATORS/WATER, ALL1 report
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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