BD BBL™ Sensi-Disc™ Ciprofloxacin 5 µg 231658Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30382902316580), received between May 5, 2022 and May 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

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

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-1027-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ SENSI-DISC¿ CIPROFLOXACIN - 5 ¿G THE ZONE OF INHABITATION WAS LARGER THAN EXPECTED. THIS A REPORT OF 1 OCCURRENCE FOR TWO BATCH NUMBERS (1127037, 1335457). NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER IS REPORTING 231658 HAS LARGER ZONE OF INHIBITION THAN EXPECTED STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER IS REPORTING THEIR 231658 DISCS FROM LOT 1127037 AND 1335457 HAVE A ZONE OF INHIBITION OF >38MM WHEN THE EXPECTED ZONE SIZE SHOULD BE 29MM TO 38MM. NO ORGANISM TYPE WAS SPECIFIED. THE CUSTOMER STATES THEY REPEATED WITH A FRESH ISOLATE AND RESULTS WERE STILL OVER >38MM. THEY RECEIVED A NEW LOT NUMBER OF DISCS, 1335458, AND THE QC PASSED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14464492 ↗
• MalfunctionMay 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE CUSTOMER BD BBL¿ SENSI-DISC¿ CIPROFLOXACIN - 5 G. THIS EVENT OCCURRED 1 TIME(S). AT THIS TIME IT IS UNCLEAR WHETHER OR NOT PATIENT SAMPLES WERE INVOLVED. THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING A ZONE OF INHIBITION FOR THEIR 231658 DISC THAT IS LARGER THAN EXPECTED", "STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER IS REPORTING THEIR 231658 DISCS FROM LOT 1127037 AND 1335457 HAVE A ZONE OF INHIBITION OF >38MM WHEN THE EXPECTED ZONE SIZE SHOULD BE 29MM TO 38MM. NO ORGANISM TYPE WAS SPECIFIED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14289083 ↗