BD BBL™ XLD Agar 221284Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10382902212840), received between Jan 28, 2021 and Aug 31, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 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 16, 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.

• MalfunctionAug 31, 2021Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE THE PLATES WERE DISCOVERED TO BE CONTAMINATED WITH BD BBL¿ XLD AGAR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392736 ↗
• MalfunctionAug 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ XLD AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THE CUSTOMER REPORTED CONTAMINATED PLATES IN A SLEEVE OF XLD AGAR PLATES FROM LOT 1095077 (ITEM 221284) ¿ PO# MC352252. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271136 ↗
• MalfunctionJun 29, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD BBL¿ XLD AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CUSTOMER STATED PLATES WERE CONTAMINATED, PRIOR TO OPENING. CUSTOMER DID NOT KNOW THE TYPE OF CONTAMINATION, BUT SAID THERE WERE YELLOW AREAS ON THE MEDIA. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084255 ↗
• MalfunctionMay 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 20 BD BBL¿ XLD AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " HOW MANY TOTAL INDIVIDUAL PLATES DID YOU SEE THE CONTAMINATION ON OUT OF THE 5 BOXES RECEIVED?: OUT OF 5 CASES (500 PLATES) APPROXIMATELY 20 TOTAL PLATES WERE NOTED. UPON VISUAL INSPECTION WAS THE CONTAMINATION: BACTERIAL OR FUNGAL?: BACTERIAL. PREVIOUS LOTS HAVE ALL BEEN IDENTIFIED AS PSEUDOMONAS FLUORESCENS SURFACE OR SUB-SURFACE?: MOSTLY SURFACE, SOME SUB-SURFACE CAN YOU PLEASE EXPLAIN FURTHER WHAT IT MEANS WHEN YOU STATE YOU ARE SEEING ABNORMAL GROWTH?: UPON RECEIPT OF THE MATERIALS, CONTAMINATION WAS OBSERVED ON NUMEROUS PLATES DISPERSED THROUGHOUT 5 CASES. DID YOU PERFORM ANY QUALITY CONTROL ON THIS LOT?: PER OUR INTERNAL PROCESSES, BECAUSE THE CONTAMINATION WAS NOTICED THROUGHOUT NUMEROUS PACKAGES WE DID NOT SUBMIT ANYTHING FOR INTERNAL QC. HOW IS THE PRODUCT STORED ONCE RECEIVED?: REFRIGERATED AT 2 ¿ 8 C. CUSTOMER PROBLEM: CUSTOMER REPORTING ABNORMAL GROWTH WITH 221284 PLATES"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787152 ↗
• MalfunctionApr 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ XLD AGAR CUSTOMER REPORTING CONTAMINATION ON 221284 PLATES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATION WITH 221284 PLATES ¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753750 ↗
• MalfunctionMar 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ XLD AGAR FOREIGN MATTER 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 11402474 ↗
• MalfunctionFeb 12, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ XLD AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A BIOFIRE RPP WAS USED TO CONFIRM 2 OF THE RESULTS AS FALSE POSITIVES. 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; No Consequences Or Impact To Patient

  MAUDE report 11325698 ↗
• MalfunctionFeb 4, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ XLD AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL WHICH CAN LEAD TO A FALSE POSITIVE. A FALSE POSITIVE MAY LEAD TO TREATMENT WITH A LESS TOLERATED ANTIBIOTIC WHICH CAN LEAD TO SERIOUS ADVERSE PATIENT CONSEQUENCE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11282542 ↗
• MalfunctionJan 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BIOLOGICAL CONTAMINATION - BACTERIAL, FUNGAL WAS FOUND ON THE NON-VIABLE BD BBL¿ XLD AGAR. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. CUSTOMER REPORTS THAT XLD PLATES RECEIVED FOR PO# 193151 ARE CONTAMINATED; ALL PLATES ARE AFFECTED. MOLDS-LIKE FORMATIONS ARE SEEN ON CLOSE OBSERVATION OF THESE PLATES.

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

  MAUDE report 11244881 ↗