BD Kiestra™ InoqulA 446973Recalls & reported problems
BD Kiestra B.V. · BD Kiestra™ InoqulA · Class 1
All models of BD Kiestra InoqulA (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382904469733), received between Oct 24, 2023 and Aug 24, 2026 — classified as 4 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. 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 Readings2
- False Negative Result1
- False Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
It has been reported that the BD Kiestra InoqulA has been found producing a false negative result. No patient impact was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50409246 ↗MalfunctionApr 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING INCORRECT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT URINE SAMPLES. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034193 ↗MalfunctionNov 3, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING BD KIESTRA INOQULA THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CULTURING HUMAN MILK FROM THE LACTARIUM WITH 250UL ON BLOOD AGAR AND 250UL ON CHAPMAN (SEARCH FOR S. AUREUS). ON THE BA, THERE IS NO S. AUREUS BUT THERE ARE LARGE QUANTITIES ON THE CHAPMAN. WE MANUALLY RE-INOCULATED THIS MILK AND WE DID NOT FIND ANY S. AUREUS CULTURE AT 24 HOURS EITHER ONBA OR ON CHAPMAN. CONCERNED DISH (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18066912 ↗MalfunctionOct 24, 2023False Negative Result; False Negative Result
IT WAS REPORTED THAT WHILE USING BD KIESTRA INOQULA, THERE WAS A FALSE NEGATIVE OF ONE SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "10 UL OF SAMPLE INOCULATED ON DRIG: (B)(4), SS: (B)(6) AND INOCULATION OF A BROTH WITH 150 UL OF SAMPLE. THE CULTURES ARE NEGATIVE ON DRIG AND SS BUT POSITIVE CULTURE AFTER ENRICHMENT. 48H AFTER FA THE CUSTOMER PROCESSED THE SAMPLE MANUALLY AND IT WENT POSITIVE .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17995089 ↗
Other DEVICE, MICROTITER DILUTING/DISPENSING devices
- BD Kiestra™ InoqulA+™ TLA 447213BD Kiestra B.V. · DEVICE, MICROTITER DILUTING/DISPENSING1 recall116 reports
- BD Kiestra™ InoqulA+™ 447202BD Kiestra B.V. · DEVICE, MICROTITER DILUTING/DISPENSING1 recall30 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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