BD Phoenix™ AST-S Broth 246007Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382902460078), received between Apr 8, 2021 and Jun 26, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K050745); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE OF BD PHOENIX¿ AST-S BROTH, THERE WERE TWO TUBES WITHOUT LABELS. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBES WITHOUT ANY LABELS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17204732 ↗
• MalfunctionAug 30, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST-S BROTH TURBIDITY WAS FOUND IN ONE OF THE CULTURE TUBES WHICH WAS SUSPECTED TO HAVE BEEN CONTAMINATED DURING PRODUCTION OR TRANSPORTATION. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND TURBIDITY IN ONE OF THE CULTURE TUBES WHEN USING THE CULTURE MEDIUM OF THIS BATCH NUMBER, WHICH WAS SUSPECTED TO HAVE BEEN CONTAMINATED DURING PRODUCTION OR TRANSPORTATION. THE CLIENT HOPES TO FIND OUT THE REASON AS SOON AS POSSIBLE AND GIVE HER A REPLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322902 ↗
• MalfunctionApr 8, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST-S BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER IS REPORTING CONTAMINATION WITH LOT 1020655."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634512 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050745. One submission often covers many models, so check the product and lot details in each record.

• Z-0934-2019 · Dec 20, 2018 · Terminated
  Phoenix AST Indicator, Catalog Number 246004
• Z-0933-2019 · Dec 20, 2018 · Terminated
  Phoenix AST-s Indicator, Catalog Number 246009
• Z-0935-2019 · Dec 20, 2018 · Terminated
  Phoenix AP AST Indicator Bag, Catalog Number 246006