BD BBL™ CHROMagar® MRSA II 215229Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 10382902152290), received between Nov 22, 2022 and Jul 10, 2025 — classified as 122 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (118 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 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Defective Device

  ON [DATE REDACTED], THE ROUTINE WEEKLY METHICILLIN RESISTANT STAPH AUREUS (MRSA) SURVEILLANCE SCREENING WAS CONDUCTED IN THE NEONATAL INTENSIVE CARE UNIT (NICU). ADDITIONAL SURVEILLANCE SWABBING WAS ALSO CONDUCTED IN THE SPECIAL CARE NURSERIES (SCN). FOLLOWING THIS SCREENING/SWABBING IN THESE SPECIFIC UNITS, TEN (10) NEW CASES OF SUSPECTED NOSOCOMIAL MRSA INFECTIONS WERE IDENTIFIED IN THESE UNITS. THE VOLUME OF POSITIVE RESULTS WAS HIGHLY UNUSUAL AND RAISED AN ALERT FOR FURTHER INVESTIGATION AND ANALYSIS. A THOROUGH EPIDEMIOLOGICAL REVIEW WAS CONDUCTED AS WELL AS GENOME SEQUENCING OF THE ISOLATES. THE TEN (10) PATIENTS WERE RE-SWABBED AND TWO (2) RESULTED AS POSITIVE BUT EIGHT (8) RESULTED AS NEGATIVE FOR MRSA AND POSITIVE FOR MSSA [METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS]. GENOME SEQUENCING OF THE ORIGINAL ISOLATES IDENTIFIED PHENOTYPIC AST-7 MSSA CONFIRMING NO RELATEDNESS BETWEEN THE CASES. THE MRSA MEDIA WAS DETERMINED TO BE FAULTY. THIS INITIAL FINDING LED TO A MORE EXTENSIVE REVIEW LED BY THE INFECTIOUS DISEASE AND INFECTION CONTROL TEAMS OF THE USE OF THE MEDIA THROUGHOUT THE HOSPITAL. IT HAS BEEN DETERMINED THAT THIS EVENT SPANNED FROM [DATE REDACTED]-[DATE REDACTED],

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 22467332 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 4 OF 5: IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II THAT ONE PATIENT SAMPLE APPEARED POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCAL AUREUS. AFTER THE QC FAILED, THE CUSTOMER PERFORMED ADDITIONAL TESTING TO CONFIRM THE PATIENT RESULT WAS METHICILLIN SUSCEPTIBLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340646 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 1 OF 5: IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II THAT ONE PATIENT SAMPLE APPEARED POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCAL AUREUS. AFTER THE QC FAILED, THE CUSTOMER PERFORMED ADDITIONAL TESTING TO CONFIRM THE PATIENT RESULT WAS METHICILLIN SUSCEPTIBLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340645 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 29 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340628 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 3 OF 5: IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II THAT ONE PATIENT SAMPLE APPEARED POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCAL AUREUS. AFTER THE QC FAILED, THE CUSTOMER PERFORMED ADDITIONAL TESTING TO CONFIRM THE PATIENT RESULT WAS METHICILLIN SUSCEPTIBLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338919 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 2 OF 5: IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II THAT ONE PATIENT SAMPLE APPEARED POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCAL AUREUS. AFTER THE QC FAILED, THE CUSTOMER PERFORMED ADDITIONAL TESTING TO CONFIRM THE PATIENT RESULT WAS METHICILLIN SUSCEPTIBLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338918 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 5 OF 5: IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II THAT ONE PATIENT SAMPLE APPEARED POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCAL AUREUS. AFTER THE QC FAILED, THE CUSTOMER PERFORMED ADDITIONAL TESTING TO CONFIRM THE PATIENT RESULT WAS METHICILLIN SUSCEPTIBLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338690 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 24 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338394 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 36 OF 40 IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338392 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 28 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338391 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 31 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338389 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 34 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338387 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 40 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338290 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 35 OF 40: IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338286 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 26 OF 40 IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338273 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 37 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338271 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 32 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338265 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 25 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338263 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 30 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338256 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 39 OF 40 IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338246 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 33 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338245 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 27 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338239 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 38 OF 40. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK/PURPLE COLONIES FOR MRSA GROWTH. WHEN THE TESTING WAS REPEATED THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338235 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 25 OF 25 IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK COLONIES FOR MRSA GROWTH AND AN UNUSUAL HIGH COUNT OF WHITE COLONIES. ADDITIONAL TESTING CONFIRMED IT WAS A FALSE POSITIVE FOR MRSA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338183 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 22 OF 25. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, THERE WERE PINK COLONIES FOR MRSA GROWTH AND AN UNUSUAL HIGH COUNT OF WHITE COLONIES. ADDITIONAL TESTING CONFIRMED IT WAS A FALSE POSITIVE FOR MRSA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337371 ↗