BD BBL™ Columbia CNA Agar with 5% Sheep Blood 221353Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10382902213533), received between Feb 26, 2021 and Sep 2, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Contamination; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569357 ↗
• MalfunctionAug 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BEFORE AND DURING USE OF BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, WHITE FUNGAL CONTAMINATION WAS OBSERVED. UNINOCULATED PLATES, PLATES USED FOR NON PATIENT TESTING, AND AN UNKNOWN NUMBER OF PLATES USED WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE INVOLVED. NO CONFIRMATORY TESTING WAS PERFORMED AND THE FUNGAL CONTAMINATE WAS NOT IDENTIFIED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22844025 ↗
• MalfunctionJun 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD THAT THERE WAS A MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUANTITY RECEIVED AND QUANTITY AFFECTED: 1 CASE. CUSTOMER REPORTING OPENED PACK AND MISSING LABEL OF PRODUCT 221353.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130762 ↗
• MalfunctionNov 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATED PLATES WITH LOT #2250542.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15841249 ↗
• MalfunctionSep 7, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THEY RECEIVED BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD THAT WAS UNMARKED WITH PLATE TYPE/LOT. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "REPORTED UNMARKED WITH PLATE TYPE/LOT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374070 ↗
• MalfunctionMar 21, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT SEVERAL BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD PLATES HAD CONTAMINATION EMBEDDED INTO THE AGAR. THERE WAS NO REPORT OF ADVERSE USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "30-40 CNA PLATES HAVE CONTAMINANTS EMBEDDED IN THE AGAR PLATES (NOT ON SURFACE)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840285 ↗
• MalfunctionNov 12, 2021Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE 3 BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD MEDIA PLATES WERE CONTAMINATED WITH BACTERIA. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION IS BACTERIAL, AND IS UNDER/IN THE AGAR. CUSTOMER STATED 2 PLATES WERE FOUND TO BE CONTAMINATED. ORGANISM NOT ID¿D. PLATES APPEAR TO BE HEMOLYZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804735 ↗
• MalfunctionMar 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11427281 ↗
• MalfunctionFeb 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING WITH BD BBL¿; COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD THERE WAS UNUSUAL BETA HEMOLYSIS FOR ENTEROCOCCUS SPECIES. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11388685 ↗