BD BBL™ Sensi-Disc™ Cefepime 30 µg 231696Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Sensi-Disc™ Cefepime 30 µg · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30382902316962), received between Apr 9, 2021 and Apr 9, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Jan 8, 2024Class IIOpen, Classified
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
Z-1018-2024 · Root cause: Process control · Recall details · FDA record ↗
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 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ SENSI-DISC¿ CEFEPIME - 30 ¿G A FALSE SUSCEPTIBILITY RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTS 231696 LOT: 0042052 HAS DISCREPANT RESULTS STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: OPENED A COMPLAINT. CUSTOMER IS PERFORMING A STUDY AND COMPARING BD SENSI DISCS TO VITEK 2 RESULTS. CUSTOMER REPORTS THAT THREE KLEBSIELLA PNEUMONIAE ESBL ISOLATES HAVE ZONES THAT INTERPRET AS RESISTANT BUT WHEN THE SAME ISOLATE IS RUN ON THE VITEK 2 THE RESULT IS SENSITIVE. FOLLOWED UP FOR ADDITIONAL DETAILS VIA PHONE BUT CUSTOMER HAS LEFT FOR THE DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11645008 ↗
Other SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL devices
- BD BBL Sensi-Disc Ampicillin 2 ug 231263Becton, Dickinson And Company · SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL2 recalls0 reports
- BD BBL™ Sensi-Disc™ Ciprofloxacin 5 µg 231658Becton, Dickinson And Company · SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL1 recall2 reports
- BD BBL™ Sensi-Disc™ Piperacillin/Tazobactam 100/10 µg 231691Becton, Dickinson And Company · SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL1 recall1 report
- BD BBL™ Sensi-Disc™ Ceftazidime 30 µg 231633Becton, Dickinson And Company · SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL1 recall1 report
- BD BBL™ Sensi-Disc™ Levofloxacin 5 µg 231706Becton, Dickinson And Company · SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL1 recall1 report
- BD BBL™ Sensi-Disc™ Chloramphenicol 30 µg 231274Becton, Dickinson And Company · SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL1 recall0 reports
- BD BBL™ Sensi-Disc™ Cefotaxime 30 µg 231607Becton, Dickinson And Company · SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL1 recall0 reports
- BD BBL™ Sensi-Disc™ Chloramphenicol - 30 µg 230733Becton, Dickinson And Company · SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL1 recall0 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 · each recall links to the FDA recall notice
- 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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