BD BBL™ MacConkey II Agar 221270Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ MacConkey II Agar, Carton of 100 plates · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD BBL MacConkey II Agar is a laboratory culture medium used to grow and distinguish bacteria. Its 63 reports mostly describe contaminated plates or media, sometimes producing incorrect test results; they include 1 injury and no deaths. There is 1 open recall, started in April 2025, because severe thunderstorms delayed transit of some cold-chain products, potentially leaving them outside labeled storage conditions and increasing incorrect or delayed test results.
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
- 64
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10382902212703), received between Jan 26, 2021 and Sep 29, 2026 — classified as 1 injury, 63 malfunctions.
The most frequently reported specific device problem is “Contamination” (25 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Apr 24, 2025Class IIOpen, Classified
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1829-2025 · Root cause: Storage · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination25
- Incorrect, Inadequate or Imprecise Result or Readings20
- Contamination of Device Ingredient or Reagent14
- Device Markings/Labelling Problem4
- Device Contamination with Chemical or Other Material2
- Microbial Contamination of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- No Patient Involvement3
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938140 ↗MalfunctionDec 8, 2025Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ MACCONKEY II AGAR, UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE CONTAMINATED. PATIENT RESULT WAS REPORTED TO THE CLINICIAN BUT THERE WERE NO HEALTH IMPACT OR CONSEQUENCES PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741754 ↗MalfunctionJul 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ MACCONKEY II AGAR, THERE WERE AN UNSPECIFIED NUMBER OF FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22575303 ↗MalfunctionMar 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD BBL¿ MACCONKEY II AGAR SOME PLATES WERE CONTAMINATED, GROWING PSEUDOMONAS AND ANOTHER GNR. THE CONTAMINATED AGAR WAS NOTICED BOTH PRIOR TO USE AND AFTER INOCULATION. NO ERRONEOUS RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18828192 ↗InjuryDec 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Contamination of Device Ingredient or Reagent; Incorrect, Inadequate or Imprecise Result or Readings; Contamination of Device Ingredient or Reagent
IT WAS REPORTED WHEN USING THE BD BBL¿ MACCONKEY II AGAR WAS CONTAMINATED, AND NOTICED SOME PLATES WERE ALREADY GROWING AN ORGANISM. AND SOME PLATES GREW THE ORGANISM AFTER INCUBATION. PATIENTS WERE TREATED BASED ON ERRONEOUS RESULTS. IT IS UNCLEAR WHAT THE TREATMENT WAS AND THE ADVERSE AFFECT OF THE TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18383643 ↗MalfunctionAug 31, 2023Contamination; Contamination
T WAS REPORTED THAT PRIOR TO USE WITH 200 BD BBL¿ MACCONKEY II AGAR THE PLATES WERE DISCOVERED TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 8/15/2023 WE RECEIVED 2,600 MACCONKEY II PLATES AND FOUND THAT 200 WERE CONTAMINATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17663343 ↗MalfunctionAug 23, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ MACCONKEY II AGAR THE PLATE WAS DISCOVERED TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED CONTAMINATION OF MACCONKEY AGAR LOT 3179199/0809/2022. THIS PLATE WAS ON TOP WHEN WE OPENED THE BOX SO IT WAS OBVIOUS BUT I DO NOT KNOW HOW MANY OTHER PLATES ARE AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17608217 ↗MalfunctionAug 3, 2023Contamination; Contamination
IT WAS REPORTED THAT BD BBL¿ MACCONKEY II AGAR HAVE SPOTS ON THE PLATE PREVENTING FROM USE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED: CUSTOMER REPORTS THERE IS SPOTS ON THE PLATE THAT PREVENT THE USE OF OUR ISOPLATER INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17455488 ↗MalfunctionJul 18, 2023Contamination; Contamination
IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ MACCONKEY II AGAR THERE WAS CONTAMINATION OF SEVEN PLATES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THE PLATE WAS CONTAMINATED UPON DELIVERY. BACTERIA - COLONY COLOR WAS PINK. 20 COUNT RECEIVED, PULLED 7 FROM USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17346747 ↗MalfunctionJun 27, 2023Contamination; Contamination
IT WAS REPORTED THAT BD BBL¿ MACCONKEY II AGAR MEDIA WAS CONTAMINATED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A CONTAMINANT INSIDE THE PLATED MEDIA UPON OPENING FROM PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17209964 ↗MalfunctionJun 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ MACCONKEY II AGAR THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS GRAM NEGATIVE ORGANISM CONTAMINATION ON 1 PLATE
Patient problems: Insufficient Information
MAUDE report 17051559 ↗MalfunctionApr 27, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ MACCONKEY II AGAR CONTAMINATED WITH H.INFLUENZA AND PARAINFLUENZA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PLATE WERE CONTAMINATED H. INFLUENZA AND PARAINFLUENZA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16825347 ↗MalfunctionFeb 8, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BD BBL¿ MACCONKEY II AGAR IS MISSING ON THE SLEEVES OF MACCONKEY II AGAR PLATES THEY RECEIVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED REPORTED THE LABEL IS MISSING ON THE SLEEVES OF MACCONKEY II AGAR PLATES THEY RECEIVED FROM LOT 2334288.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16318644 ↗MalfunctionNov 24, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ MACCONKEY II AGAR CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 30 PACKS OF CONTAMINATED PLATED MEDIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15863862 ↗MalfunctionOct 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ MACCONKEY II AGAR HAD 4 CONTAMINATED PLATES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATED PLATES - LOT # 2194484.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15544788 ↗MalfunctionSep 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ MACCONKEY II AGAR HAD CONTAMINATED PLATES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATED PLATES - LOT #2194484.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15465443 ↗MalfunctionJul 15, 2022Contamination; Contamination
IT WAS REPORTED THAT PRIOR TO USE, 20 BD BBL¿ MACCONKEY II AGAR PLATES WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: 221270 MACCONKEY PLATES CONTAMINATION. QUANTITY RECEIVED AND QUANTITY AFFECTED: 7 CT RECEIVED, 20 PLATES CONTAMINATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15029089 ↗MalfunctionJul 6, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
IT WAS REPORTED WHEN USING THE MEDIA, BD BBL MACCONKEY II AGAR, BIOLOGICAL CONTAMINATION WAS OBSERVED. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT FOUND ABOUT 80 PLATES THAT WERE CONTAMINATED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14939051 ↗MalfunctionJun 30, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND ABOUT 20 PLATES OF, BD BBL¿ MACCONKEY II AGAR THAT WERE HEAVILY CONTAMINATED. THIS OCCURRED ONE TIME IN THIS EVENT AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER, "ON (B)(6) 2022, WE RECEIVED 7 CASES (100 PLATES/CA) OF ITEM # 221270 (LAWSON # 6320871) ON PO #12657243 FROM CARDINAL. WE HAVE FOUND ABOUT 20 PLATES THAT ARE HEAVILY CONTAMINATED WITH WHAT APPEARS TO BE A MIXTURE OF ORGANISMS. THESE WERE FROM LOT#: 209147 (EXP 07/07/22) WITH VARIOUS TIME STAMPS ON THEM, RANGING FROM 1945 TO 1954."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14881936 ↗MalfunctionJun 29, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHILE USING BD BBL¿ MACCONKEY II 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 " "CARDINAL HEALTH COMPLAINT HANDLING ANALYST" REPORTS THAT CUSTOMER REPORTS THAT THEY RECEIVED SOME CONTAMINATED MACCONKEY II AGAR TODAY, AT LEAST 7 SLEEVES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14862088 ↗MalfunctionJun 27, 2022Contamination; Contamination
IT WAS REPORTED THAT PRIOR TO USE, BD BBL¿ MACCONKEY II AGAR PLATES WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAT#221270 LOT#2109300 PLATES HAVE CONTAMINATION GROWING INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14836655 ↗MalfunctionJun 6, 2022Contamination; Contamination
IT WAS REPORTED THAT 2 PLATES OF BD BBL¿ MACCONKEY II AGAR WAS CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS 221270_2056460 CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14604631 ↗MalfunctionMay 23, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
IT WAS REPORTED THAT BD BBL¿ MACCONKEY II AGAR WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER IS REPORTING CONTAMINATION WITH THEIR PLATES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14470555 ↗MalfunctionMay 20, 2022Contamination; Contamination
IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT, BD BBL¿ MACCONKEY II AGAR HAD CONTAMINATION. THERE WERE 8 OCCURRENCES IN THIS 1 EVENT. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER IS REPORTING CONTAMINATION WITH THEIR 221270 PLATES FROM LOT 2040749"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14457379 ↗MalfunctionMay 12, 2022Contamination; Contamination
IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ MACCONKEY II AGAR THE CUSTOMER OBSERVED BIOLOGICAL CONTAMINATION OF THE MEDIA. THIS EVENT OCCURRED 210 TIME(S). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS CONTAMINATION", "CUSTOMER REPORTS 210 PLATES AT LEAST."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14370596 ↗
Other CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL devices
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- CHROMID® Candida AgarBiomerieux SA · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL1 recall28 reports
- CHROMID® C. difficileBiomerieux SA · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL1 recall3 reports
- REMEL R02049Remel, Inc. · Culture Media, Selective And Differential1 recall0 reports
- Strep Selective II Agar R01859Remel, Inc. · Culture Media, Selective And Differential1 recall0 reports
- BD BBL™ CHROMagar™ Candida 254093Becton, Dickinson And Company · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL29 reports
- CHROMID® S. aureus Elite agarBiomerieux SA · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL9 reports
- BD BBL™ Hektoen Enteric Agar 221365Becton, Dickinson And Company · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL6 reports
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 · each recall links to the FDA recall notice
- 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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