BD BBL™ Urease Test Broth 221719Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Urease Test Broth, 3 mL, Package of 10 size K tubes · Class 1
Data updated Oct 16, 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 30382902217191), received between Apr 24, 2023 and Apr 24, 2023 — 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 16, 2026.
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.
MalfunctionApr 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ UREASE TEST BROTH THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTED LOT#: 3039044 SHOWING NO REACTION AT ALL WHEN INOCULATED WITH PROTEUS SP. CUSTOMER REPORTS IN THE PAST THEY USED TO ORDER THE 10X CONCENTRATION TUBES (221098), BUT SINCE THEY DISCONTINUED THE PRODUCT, THEY GOT PRODUCT 221719 AS AN ALTERNATIVE. CUSTOMER REPORTS THEY HAVE AT LEAST RECEIVED ONE PREVIOUS LOT OF 221719 BEFORE ND IT REACTED NORMALLY, HOWEVER WHEN THEY CHANGED TO LOT#: 3039044 , THEY HAVE NOT GOTTEN ANY REACTION ON ANY OF THE TUBES. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: LOT#: (B)(6). HAZARD, INJURY OR ERRONEOUS RESULTS? YES; HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS NO REACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16801217 ↗
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- BD BBL™ Rapid Urea Broth 298330Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL2 reports
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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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