BD BBL™ Enriched Thioglycollate Medium 221742Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 30382902217429), received between Jul 3, 2019 and Aug 25, 2025 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, THERE WERE FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885042 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, THERE WERE FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884975 ↗
• MalfunctionJun 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCUBATED FOR 7 DAYS AT 37C. NOT VISUALLY TURBID PRIOR TO USE. BROTH SUBCULTURED TO BAP, CHOC, MAC AND CDC. GRAM STAIN PERFORMED MANUALLY AND AUTOMATICALLY. GRAM STAIN RESULT: "GRAM VARIABLE RODS- BOX CAR BACILLUS LOOKING". 3 BOXES RECEIVED - ALL 300 TUBES AFFECTED. WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT - NO ERRONEOUS RESULTS WERE REPORTED CUSTOMER REPORTS FINDING NON-VIABLE RODS WHEN GRAM STAINING THE THIO BROTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134708 ↗
• MalfunctionMar 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CONTAMINATION WAS FOUND. IN 8 BOXES OF PRODUCT. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT HAS NON VIABLE CONTAMINATION RESEMBLING A BACILLUS OR CLOSTRIDIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475778 ↗
• MalfunctionJan 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN VIALS WERE FOUND OVERLY TURBID AND AFTER TESTING WAS DEEMED UNUSABLE FOR PATIENT TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBES RECEIVED 11/27 AND REFRIGERATED UNTIL ATTEMPTED USE. UPON OPENING BOX, VIALS WERE FOUND TO BE OVERLY TURBID. GRAM STAINS WERE PERFORMED. GRAM NEG RODS AND GRAM VARIABLE RODS SEEN. BOTH ARE NONVIABLE UPON SUBCULTURE. PRODUCT WAS DEEMED UNUSABLE FOR PATIENT TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142202 ↗
• MalfunctionDec 30, 2022Contamination; Contamination

  IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN WERE OPAQUE AND DAMAGED CONSIDERING THE PRODUCT CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT WAS OPAQUE AND DAMAGED, THEY ARE DEEMING THE PRODUCT CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16078224 ↗
• MalfunctionAug 30, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED BY THE CUSTOMER THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, LOT: 1322739 NOTED THAT ABOUT HALF OF THE BOX WAS A LITTLE FUZZY PLATED AND NO GROWTH. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "IT WAS REPORTED BY THE CUSTOMER INSIDE LOT: 1322739 NOTED THAT ABOUT HALF OF THE BOX WAS A LITTLE FUZZY. PLATED AND NO GROWTH. INCUBATED AT 37C FOR 48 HOURS AND IT WAS MORE FUZZIER/CLOUDY. NO GRAM STAIN PERFORMED. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15323633 ↗
• MalfunctionJan 5, 2022Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE 29 TUBES OF BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN WERE DISCOVERED TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTED CONTAMINATION ON TUBES OF MEDIA 221742 WITH LOT#: 1238117.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171960 ↗
• MalfunctionDec 15, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE, BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN TUBES WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS CONTAMINATION ON MEDIA 221742 WITH LOT#: 1238117 RIGHT OUT OF THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012314 ↗
• MalfunctionMay 26, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN THE MEDIA APPEARS CLOUDY. GRAM STAIN SHOWED MANY NON-VIABLE ORGANISMS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER STATED MEDIA IS CLOUDY, PRIOR TO INOCULATION. GRAM STAIN SHOWS MANY NON-VIABLE ORGANISMS. GRAM STAIN SHOWED GRAM NEGATIVE BACILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887216 ↗
• MalfunctionApr 27, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN TEST WAS USED TO CONFIRM THE CONTAMINATION. 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: " FOLLOW UP CALL PLACED TO CUSTOMER. CUSTOMER CONFIRMED RECEIPT OF BOX OF THIO BROTHS. CUSTOMER STATES THE BACILLUS SP. THEY FOUND IN THE TUBES WAS NOT REPORTED OUT FOR ANY PATIENTS AND NO ERRONEOUS RESULTS WERE ISSUED. NO PATIENT TREATMENT WAS AFFECTED. CUSTOMER IS REQUESTING REPLACEMENT FOR THE SECOND BOX OF BROTHS TUBES THEY RECEIVED SINCE THE ISSUE WAS IN BOTH BOXES. I LET CUSTOMER KNOW THAT THE SECOND BOX CAN BE REPLACED WHEN AND IF THE QUALITY INVESTIGATION IS CONFIRMED. IT WAS REPORTED THAT CUSTOMER HAS LARGE GRAM POSITIVE BACILLUS CONTAMINATION IN 221742 LOT 0302188 TUBES. CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATION IN 221742 TUBES. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER CALLED IN REPORTING CONTAMINATION IN 221742 LOT 0302188 TUBES. THEY RECEIVED TWO BOXES OF THE TUBES AND TOWARDS THE EN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732805 ↗
• MalfunctionSep 6, 2019Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, NON-VIABLE GRAM-NEGITIVE RODS (GNR) WERE OBSERVED AND ERRONEOUSLY REPORTED TO THE HOSPITAL MICROBIOLOGIST. NO INFORMATION WAS AVAILABLE ON HOW PATIENT TREATMENT WAS CHANGED OR IF TREATMENT WAS CHANGED. NO MISDIAGNOSIS OR WORSENING IN PATIENT CONDITION WAS INDICATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8970317 ↗
• MalfunctionSep 3, 2019Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN TO CULTURE PATIENT SAMPLES THE LAB OBSERVED NON-VIABLE GRAM NEGATIVE RODS. THE RESULTS WERE ERRONEOUSLY REPORTED TO THE MICROBIOLOGIST AND THE CUSTOMER WAS UNAWARE IF PATIENTS' TREATMENTS WERE CHANGED. TWO LOT NUMBERS WERE REPORTED TO BE INVOLVED BUT NO MISDIAGNOSIS OR WORSENING OF CONDITION WAS INDICATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8956020 ↗
• MalfunctionAug 22, 2019Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN TO CULTURE PATIENT SAMPLES THE LAB OBSERVED NON-VIABLE ORGANISMS. AFTER A GRAM STAIN, THE PATIENT RESULT WAS ERRONEOUSLY REPORTED AS GRAM-NEGATIVE RODS. NO INFORMATION WAS AVAILABLE ON HOW THE PATIENT TREATMENT WAS CHANGED OR IF TREATMENT WAS CHANGED. NO MISDIAGNOSIS OR WORSENING IN PATIENT CONDITION WAS INDICATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8920831 ↗
• MalfunctionAug 20, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CONTAINED GRAM NEGATIVE ROD NON-VIABLES ON THE GRAM STAINS, ALTHOUGH THE ORGANISMS DIDN'T GROW IN THE CULTURES. THE RESULTS WERE INITIALLY REPORTED OUT TO THE CAREGIVERS AND THEN CORRECTED AFTER, BUT THEY ARE NOT SURE IF THE PATIENT TREATMENT WAS AFFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8912588 ↗
• MalfunctionAug 5, 2019Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN A REFERENCE LAB OBSERVED NON-VIABLE ORGANISMS PRESENT IN THE MEDIA. THE RESULTS OF GRAM STAINS WERE ERRONEOUSLY REPORTED AS GRAM-NEGATIVE RODS FOR ONE PATIENT. CULTURE OF THE MEDIA DID NOT SHOW SIGNS OF MICROBIAL GROWTH. NO INFORMATION WAS AVAILABLE ON HOW THE PATIENT TREATMENT WAS CHANGED OR IF TREATMENT WAS CHANGED. NO MISDIAGNOSIS OR WORSENING IN PATIENT CONDITION WAS INDICATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8862050 ↗
• InjuryJul 12, 2019Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN TO CULTURE PATIENT SAMPLES THE LAB OBSERVED NON-VIABLE ORGANISM CONTAMINATION. THE PATIENT RESULTS WERE ERRONEOUSLY REPORTED AS GRAM-NEGATIVE RODS FOR 2 PATIENT SAMPLES. NO INFORMATION WAS AVAILABLE ON HOW THE PATIENT TREATMENT WAS CHANGED OR IF TREATMENT WAS CHANGED. NO MISDIAGNOSIS OR WORSENING IN PATIENT CONDITION WAS INDICATED. THE CUSTOMER NOTED 10 TUBES OF MEDIA WERE IMPACTED IN TOTAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8785656 ↗
• MalfunctionJul 3, 2019Material Opacification; Incorrect, Inadequate or Imprecise Result or Readings; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM WAS CLOUDY AND CONTAMINATED WITH GRAM-NEGATIVE RODS. THE CUSTOMER INDICATED THAT 15 DIFFERENT PATIENT SAMPLES DID NOT EXHIBIT SIGNS OF BACTERIAL GROWTH IN CULTURE MEDIA. THE PHYSICIANS WERE NOTIFIED BUT UNABLE TO DETERMINE IF ANY PATIENTS HAD BEEN TREATED OR TREATMENT CHANGED DUE TO THE ERRONEOUS RESULTS. CUSTOMER IS INVESTIGATING AND BD WILL CONTINUE TO MAKE THE NECESSARY FOLLOW-UP ATTEMPTS TO GAIN FURTHER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8760215 ↗