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BD BBL™ Levine EMB Agar 221268Recalls & reported problems

Becton, Dickinson And Company · BD BBL™ Levine EMB Agar · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10382902212680), received between Aug 3, 2021 and Feb 14, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 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

Device problems

  • Contamination3
  • Incorrect, Inadequate or Imprecise Result or Readings2

Patient problems

  • No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 14, 2022Contamination; Contamination

    IT WAS REPORTED THAT THE BD BBL¿ LEVINE EMB AGAR WAS CONTAMINATED. THERE WAS NO REPORT OF USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "POLLUTION".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13524523 ↗
  • MalfunctionNov 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    IT WAS REPORTED THAT BD BBL¿ LEVINE EMB AGAR WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOULDY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12739625 ↗
  • MalfunctionAug 25, 2021Contamination; Contamination

    IT WAS REPORTED THAT WHILE USING 3 BD BBL¿ LEVINE EMB 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: " CUSTOMER STATES CONTAMINATION WAS FOUND IN 3 PLATES WHILE UNPACKING. PRODUCT WAS REFRIGERATED UPON RECEIPT. ORGANISMS RECOVERED WAS IDENTIFIED AS PSEUDOMONAS SP NO P. AERUGINOSA, PSEUDOMONAS FLUORESCENS GROUP. "

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12366397 ↗
  • MalfunctionAug 6, 2021Contamination; Contamination

    IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ LEVINE EMB 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: " PLATES SEEN WITH MICROBIAL GROWTH BEFORE USE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12292036 ↗
  • MalfunctionAug 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    IT WAS REPORTED THAT WHILE USING BD BBL¿ LEVINE EMB 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 REPORTS CONTAMINATED PLATE FOR CAT 221268 LOT 1134770. "

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12271223 ↗

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Sources and updates

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