BD BBL™ Mueller Hinton II Agar 221800Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10382902218002), received between Nov 15, 2021 and Sep 15, 2023 — classified as 11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ MUELLER HINTON II AGAR THAT THERE A PERFORMANCE ISSUE WITH GROWTH. THIS OCCURRED TO APPROXIMATELY 400 PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING THEY ARE NOT GETTING THE DENSE APPEARANCE ON THE AGAR. AFFECTED LOT NUMBER 3115025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760919 ↗
• MalfunctionJun 14, 2023Contamination; Contamination

  REPORT 2 OF 2. IT WAS REPORTED THAT A BD BBL¿ MUELLER HINTON II AGAR PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN ADDITIONAL PLATE WAS PULLED FOR STERILITY ON THE 16TH. IT NOW HAS THREE COLONIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131381 ↗
• MalfunctionJun 14, 2023Contamination; Contamination

  REPORT 1 OF 2 IT WAS REPORTED THAT A BD BBL¿ MUELLER HINTON II AGAR PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT THEY PULLED A PLATE FOR STERILITY UPON RECEIPT. THE PLATE GREW 2 COLONIES, ONE OF WHICH WAS A FUNGUS AND HAS SPREAD OVER MOST OF THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131272 ↗
• MalfunctionJun 12, 2023Low pH; Low pH

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ MUELLER HINTON II AGAR THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATES PRODUCT PH IS MEASURING TOO LOW (MULTIPLE CALIBRATIONS AND TESTING ATTEMPTS PERFORMED). LOT # 3094846 PH MEASURING 7.13/7.12 AND LOT # 3101064 PH MEASURING 7.11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17112076 ↗
• MalfunctionOct 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) WAS RECEIVED CONTAMINATED. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THE FOC FROM CASE #(B)(4) WERE RECEIVED CONTAMINATED. LOT #2196602.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15560845 ↗
• MalfunctionOct 6, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ MUELLER HINTON II AGAR HAS SEVEN OCCURRENCES OF CONTAMINATION. THE PRODUCT IS CLOUDY AND HAS CHANGED COLOR. THE MEDIA CONTAMINATION WAS NOTICED UPON RECEIVING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES MEDIA IS CONTAMINATED. PRODUCT IS CLOUDY AND HAS CHANGED COLOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552419 ↗
• MalfunctionApr 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ MUELLER HINTON II AGAR THE CUSTOMER OBSERVED THAT THE MEDIA HAD ATYPICAL GROWTH. THIS EVENT OCCURRED 1 TIME(S). 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] REPORTED FURTHER GROWTH ISSUES WITH THEIR M. LUTEUS STRAIN WHEN TESTING THE NEW LOT OF MUELLER HINTON II AGAR PLATES RECEIVED (LOT 2020098 / 0800/ 2022/05/02). ACCORDING TO THE ATTACHED PHOTO, THEIR M. LUTEUS STRAIN IS GROWING WELL ON THEIR OLD (EXPIRED) LOT 1211750 BUT IT'S NOT GROWING ON THE TWO LAST LOTS RECEIVED (1347273 AND 2020098). THE SAME BROTH TUBE WAS USED TO INOCULATE THE 3 LOTS AND THE PLATES WERE ALL INCUBATED AT 37 DEGREES C FOR 48H."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14173966 ↗
• MalfunctionApr 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT 6 BD BBL¿ MUELLER HINTON II AGAR PLATES HAD DIFFERING BACTERIAL GROWTH RESULTS DESPITE BEING FROM THE SAME BROTH. NEW TESTS WERE PERFORMED WITH FRESH BROTH AND MATERIALS, BUT THERE WAS NO GROWTH FOR M. LUTEUS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED GROWTH ISSUES WITH ONE OF THEIR BACTERIA (MICROCOCCUS LUTEUS) WHEN TESTING THE MUELLER HINTON PLATES RECEIVED FROM LOT 1347237. DIFFERENT RESULTS WERE OBTAINED WHEN TESTING THE SAME BACTERIA (FROM THE SAME BROTH) ON PLATES FROM THEIR PREVIOUS LOT AND THE CURRENT LOT. THE BACTERIA ONLY GREW ON THE PLATE FROM THE PREVIOUS LOT." "THE BROTHS USED DURING THE TESTING WERE 24-36 HOURS OLD. WE REDID EVERYTHING WITH FRESH MATERIAL AND ATTEMPTED AT LEAST 10 DIFFERENT TRIALS ON THIS BATCH AND NONE HAD ANY GROWTH FOR M. LUTEUS." "YES, THERE WAS GROWTH FOR THE FOLLOWING BACTERIA: BACILLUS THURINGIENSIS, ENTEROBACTER ASBURIAE AND STAPHYLOCOCCUS EPIDERMIDIS." "THEIR M. LUTEUS STRAIN IS GROWING WELL ON THEIR OLD (EXPIRED) LOT 1211750 BUT IS NOT GROWING ON THE NEWS LOTS RECEIVED (1347273 AND 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087803 ↗
• MalfunctionApr 6, 2022Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE BD BBL¿ MUELLER HINTON II AGAR PLATE WAS FOUND CONTAMINATED WITH MICROBIAL GROWTH BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED PLATES , PACKAGE ARRIVED WITH RIGHT TEMPERATURE AND PACKAGING." "THE MICROBIAL GROWTH WAS OBSERVED DURING THE VISUAL INSPECTION WHEN THE MATERIAL ARRIVED AT THE LABORATORY. THE STORAGE OF THE MATERIAL WAS AS PER RECEIVED (ICE PACKS)." "WE RECEIVED 6 CASES (144 PLATES), ONLY ONE PLATE SHOWED MICROBIAL GROWTH, THIS DOES NOT ALLOW US TO RECEIVE THE MATERIAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14025394 ↗
• MalfunctionJan 6, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE, BD BBL¿ MUELLER HINTON II AGAR PLATES WERE CONTAMINATED WITH MOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTRIBUTOR REPORTS MOLD CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177686 ↗
• MalfunctionNov 15, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BACTERIAL CONTAMINATION WAS FOUND ON THE BD BBL¿ MUELLER HINTON II AGAR PREPARED MEDIA. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED TO HAVE RECEIVED 14 BOXES OF 24 PLATES WITH LOT#: 1246433 WITH EXPIRATION DATE OF 12/16/21." "ONLY ONE PLATE WAS OBSERVED WITH BACTERIAL CONTAMINATION"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814168 ↗