BD BBL Sensi-Disc Levofloxacin 5 µgRecalls & reported problems across all models

We found 2 models of BD BBL Sensi-Disc Levofloxacin 5 µg by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Mar 15, 2023 and Mar 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BD BBL Sensi-Disc Levofloxacin 5 µg recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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-1032-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported BD BBL Sensi-Disc Levofloxacin 5 µg problems

BD BBL Sensi-Disc Levofloxacin 5 µg models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD BBL™ Sensi-Disc™ Levofloxacin 5 µg 231706

  SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
  1 recall1 report
• BD BBL™ Sensi-Disc™ Levofloxacin 5 µg 231705

  SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
  1 recall0 reports

Recent BD BBL Sensi-Disc Levofloxacin 5 µg adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ SENSI-DISC¿ LEVOFLOXACIN - 5 GM THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. WHEN STAFF OF STORAGE CHECK PRODUCT TO DELIVER FOR CUSTOMER, THEY SAW INFORMATION ON THE LABEL OF BOX NOT MATCH WITH CONTENT OF THIS BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550464 ↗

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