BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™) 221267Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and BD IsoVitaleX™), Ctn. of 100 plates · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Becton Dickinson BD BBL Chocolate II Agar plate, a laboratory culture medium used to grow bacteria from patient samples. The 39 reports mostly describe mold or fungal contamination in plates or sleeves, and plates that grew patient samples poorly or not at all, plus a few sleeves missing labels. No deaths and no injuries are reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10382902212673), received between Jan 7, 2021 and Sep 4, 2026 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (22 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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings22
- Contamination16
- Device Markings/Labelling Problem2
- Contamination of Device Ingredient or Reagent1
- Device Contaminated During Manufacture or Shipping1
- Microbial Contamination of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Insufficient Information1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Contamination; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616647 ↗MalfunctionSep 4, 2026Contamination; Incorrect, Inadequate or Imprecise Result or Readings
It was reported that while using BD BBL¿ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX¿), the customer observed mold/fungal contamination on an unspecified number of plates following inoculation. No adverse health impact, patient harm, or other consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616639 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED WHILE USING BD BBL¿ CHOCOLATE II AGAR, PATIENT SAMPLE WAS CONTAMINATED WITH MOLD. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960953 ↗MalfunctionSep 4, 2025Contamination; Contamination
IT WAS REPORTED WHILE USING BD BBL¿ CHOCOLATE II AGAR, PATIENT SAMPLE WAS CONTAMINATED WITH MOLD. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960950 ↗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¿ CHOCOLATE II AGAR, 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 22844064 ↗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¿ CHOCOLATE II AGAR, 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 22843042 ↗MalfunctionApr 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ CHOCOLATE II AGAR THAT TWO (2) PLATES HAD INSUFFICIENT GROWTH OF PATIENT SAMPLES. THE LOT FAILED GROWTH PROMOTION TESTING USING A QUALITY CONTROL HAEMOPHILUS INFLUENZAE STRAIN. IT WAS NOTED THAT THE PATIENT SAMPLES HAD GROWTH ON THE ACCOMPANIED BLOOD AGAR PLATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21862894 ↗MalfunctionApr 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ CHOCOLATE II AGAR THAT FOUR (4) PLATES HAD INSUFFICIENT GROWTH OF PATIENT SAMPLES. THE LOT FAILED GROWTH PROMOTION TESTING USING A QUALITY CONTROL HAEMOPHILUS INFLUENZAE STRAIN. IT WAS NOTED THAT THE PATIENT SAMPLES HAD GROWTH ON THE ACCOMPANIED BLOOD AGAR PLATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21853236 ↗MalfunctionMar 20, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING BD BBL¿ CHOCOLATE II AGAR THAT THREE (3) SLEEVES OF MEDIA WERE MISSING THE PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21652364 ↗MalfunctionOct 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ CHOCOLATE II AGAR THAT A MOLD CONTAMINANT WAS OBSERVED AN UNSPECIFIED NUMBER OF TIMES DURING INCUBATION OF PATIENT SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20563234 ↗MalfunctionOct 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ CHOCOLATE II AGAR THAT A MOLD CONTAMINANT WAS OBSERVED AN UNSPECIFIED NUMBER OF TIMES DURING INCUBATION OF PATIENT SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20533326 ↗MalfunctionOct 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ CHOCOLATE II AGAR HAD AN UNSPECIFIED NUMBER OF PLATES WITH FUNGAL CONTAMINATION OBSERVED BEFORE AND DURING USE. APPROXIMATELY THREE (3) SAMPLES WERE REPORTED AS MOLD WITH A COMMENT OF "PROBABLE CONTAMINANT". THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20418556 ↗MalfunctionFeb 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) BIOLOGICAL CONTAMINATION WAS FOUND ON ONE PATIENT'S SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18778538 ↗MalfunctionAug 23, 2023Contamination; Contamination
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) THAT THERE WAS BIOLOGICAL CONTAMINATION 80 PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHOCOLATE AGAR PLATES WERE FOUND TO BE CONTAMINATED ON DELIVERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17607394 ↗MalfunctionFeb 27, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) FUNGAL GROWTH WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON OPENING OF THE PACKAGING OF OUR 221267 BBL PLATED MEDIA, FUNGAL GROWTH IS SEEN IN THE INSIDE OF THE PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16444991 ↗MalfunctionNov 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX) FAILED GROWTH PROMOTION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS HAEMOPHILUS FAILED TO GROW ON 221261 - LOT #2228641. "HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15757235 ↗MalfunctionOct 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) HAS HAD AN INCREASE IN CONTAMINATION. THERE WERE SIX TOTAL PLATES CONTAMINATED FOR LOTS 2196578 AND 2196579. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING AN INCREASING INCIDENCE OF CONTAMINATED CHOC PLATES (ITEM # 221267) RECEIVED 22ND AND 27TH SEP WITH LOT NUMBERS 2196578 AND 2196579.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15636572 ↗MalfunctionOct 11, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) HAD ATYPICAL COLONY MORPHOLOGIES GROWING ON PRODUCT. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING ATYPICAL COLONY MORPHOLOGIES GROWING ON PRODUCT 221267, LOT 2206461.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15580590 ↗MalfunctionSep 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) HAD CONTAMINATED PLATES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATED PLATES - LOT #2174113.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15472483 ↗MalfunctionAug 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER PRODUCT 221267 WAS CONTAMINATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15259005 ↗MalfunctionMar 15, 2022Contamination; Contamination
IT WAS REPORTED THAT THE BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF ADVERSE USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13765542 ↗MalfunctionJan 14, 2022Contamination; Contamination
IT HAS BEEN REPORTED THAT THE BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) HAS BEEN FOUND CONTAMINATED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE CONTAMINATION ON ONE PLATE IN LOT 1301556.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13260550 ↗MalfunctionDec 28, 2021Contamination; Contamination
IT WAS REPORTED THAT PRIOR TO USE, ONE BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) PLATE WAS CONTAMINATED WITH PSEUDOMONAS FLUORESCENS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES CONTAMINATION WAS FOUND IN 1 PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13097118 ↗MalfunctionNov 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) EXPERIENCED BIOLOGICAL CONTAMINATION WHICH WAS OBSERVBED BY LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12832425 ↗MalfunctionOct 18, 2021Contamination; Contamination
IT WAS REPORTED THAT PRIOR TO USE WITH 8 BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) CONTAMINATION WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CONTAMINATION WITH 221267 PLATES LOT 1211739.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12649341 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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