BD BACTEC™ Peds Plus™/F Culture Vials 442020Recalls & reported problems
Becton, Dickinson And Company · BD BACTEC™ Peds Plus™/F Culture Vials, Case of 50 vials · Class 1
All models of BD BACTEC Peds Plus/F Culture Vials (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These BD BACTEC Peds Plus blood culture vials are bottles used to culture blood samples from patients, including children. Of its 354 reports, 343 describe malfunctions and 11 describe injuries, with no deaths. Most describe false positive results, and others describe incorrect results or biological contamination of the sample. No recalls name this device, and reports fell to 8 in the last 12 months from 102 before that.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 355
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 355 adverse event reports that list this exact device (DI 00382904420208), received between Jan 26, 2021 and Aug 24, 2026 — classified as 10 injuries, 345 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (205 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
- False Positive Result205
- Incorrect, Inadequate or Imprecise Result or Readings68
- Contamination59
- False Negative Result12
- Device Markings/Labelling Problem9
- Contamination of Device Ingredient or Reagent3
- Device Contamination with Chemical or Other Material2
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions339
- No Consequences Or Impact To Patient17
- Insufficient Information6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Local Reaction1
Recent adverse event reports
The 25 most recent of 355 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50408870 ↗MalfunctionAug 21, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379903 ↗MalfunctionAug 18, 2026False Negative Result
It was reported while using BD BACTEC¿ Peds Plus¿/ F Culture Vials (plastic), there was one false negative result. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303791 ↗MalfunctionFeb 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS NIALLIA CIRCULANS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343810 ↗MalfunctionFeb 16, 2026Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), THE LABEL INFORMATION LISTED ON ONE BOTTLE WAS INCORRECT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343807 ↗MalfunctionFeb 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS NIALLIA CIRCULANS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343800 ↗MalfunctionJan 14, 2026False Negative Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067281 ↗MalfunctionNov 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS CANDIDA PARAPSILOSIS . NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532507 ↗MalfunctionNov 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE IDENTIFIED AS CANDIDA PARAPSILOSIS . NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532503 ↗MalfunctionSep 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22976657 ↗MalfunctionSep 5, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22975204 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960993 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960991 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960989 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960987 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960985 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960984 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960983 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960982 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960981 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960980 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960979 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960977 ↗MalfunctionSep 3, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951979 ↗MalfunctionSep 3, 2025Contamination; Contamination
IT WAS REPORTED THAT A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) TUBE WAS FOUND TO BE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951973 ↗
Other SYSTEM, BLOOD CULTURING devices
- BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 245122Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING1,472 reports
- BD BACTEC™ Plus Aerobic/F Culture Vials 442023Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING2 deaths1,063 reports
- BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials 442021Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING1 death791 reports
- BD BACTEC™ FX Top 441385Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING2 recalls1 death475 reports
- BD BACTEC™ Plus Anaerobic/F Culture Vials 442022Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING237 reports
- BD BACTEC™ MGIT™ 960 Instrument 445870Becton, Dickinson And Company · SYSTEM, BLOOD CULTURING186 reports
- BACT/ALERT® FA PLUSBiomerieux , Inc. · System, blood culturing1 recall126 reports
- BACT/ALERT® PF PLUSBiomerieux , Inc. · System, blood culturing1 recall124 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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