BD BBL™ CHROMAgar™ Orient/TSA II W/5% SB 222239Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10382902222399), received between Feb 19, 2021 and Jan 13, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (20 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING ONE BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB, THE CUSTOMER NOTICED ROSE TO PINK COLONIES SIMILAR TO E. COLI, BUT SLIGHTLY LARGER, AND MALDI CONFIRMED AS SALMONELLA. THE SALMONELLA WAS NOT ERRONEOUSLY REPORTED, AND CUSTOMER HAS NO INFORMATION ON PATIENT TREATMENT CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054138 ↗
• MalfunctionJan 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING ONE BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB, THE CUSTOMER NOTICED MEDIUM SIZED, DARK ROSE TO PINK, TRANSPARENT COLONIES THAT WERE ORIGINALLY THOUGHT TO BE E. COLI, BUT MALDI CONFIRMED AS CITROBACTER. THE CITROBACTER WAS RELEASED TO PHYSICIAN BUT WAS LATER CORRECTED TO E. COLI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053720 ↗
• MalfunctionJul 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584648 ↗
• MalfunctionJul 7, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿. MEDIA WAS CONTAMINATED PRIOR TO USE. THIS OCCURRED 25 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THEY ARE GETTING CONTAMINATED PLATES RIGHT FROM THE PACKAGING ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280921 ↗
• MalfunctionJun 21, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ THE CUSTOMER OBSERVED BIOLOGICAL CONTAMINATION OF THE MEDIA. THIS EVENT OCCURRED 20 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: "THE MEDIUM HAS BEEN CONTAMINATED AND DISCOLOR.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14761140 ↗
• MalfunctionMar 8, 2022Contamination; Contamination

  IT WAS REPORTED WHILE TESTING WITH BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ BIOLOGICAL CONTAMINATION WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PLATES HAD DISCOLORATION. CUSTOMER ALSO PROVIDED PICTURES WHICH REVEAL BIOLOGICAL CONTAMINATION. QUANTITY RECEIVED AND QUANTITY AFFECTED: 105 RECEIVED. 68 OF LOT 1337221 WERE CRACKED. 42 OF 1316562 WERE CRACKED. 30 OF 1343366 HAD UNEQUAL FILL. 12 OF 1316562 HAD UNEQUAL FILL. 18 OF 1337221 HAD UNEQUAL FILL. 20 OF 1337221 WERE DISCOLORED, AND 30 OF 1316562 WERE DISCOLORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698900 ↗
• MalfunctionMar 4, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING 23 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ 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: " YES, PRODUCT CONTAMINATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673596 ↗
• MalfunctionNov 15, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE 20 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W (B)(6) (TSA II)-I PLATE¿ THAT WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816351 ↗
• MalfunctionOct 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR PLATE¿ 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: '' IT WAS REPORTED THAT CONTAMINATION ON PRODUCT 22239 WITH LOT#: 1211703".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685956 ↗
• MalfunctionSep 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ HAD 20 PLATES OF EACH LOT THAT HAD "MOLDY" CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOLDY, POLLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434457 ↗
• MalfunctionSep 3, 2021Contamination; Contamination

  IT WAS REPORTED THAT A PLATE OF BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ WAS CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER HAS ONE PLATE CONTAMINATED WITH 222239 PLATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425187 ↗
• MalfunctionSep 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE 80 OCCURRENCES WITH EACH LOT NUMBER REPORTED OF BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ THAT HAD CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE MEDIUM HAS BEEN CONTAMINATED BEFORE BEING USED. (NO PHOTOS WERE TAKEN, BUT THE STAFF CONFIRMED ON THE SPOT)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425186 ↗
• MalfunctionSep 1, 2021Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ 30 PLATES HAD VISIBLE CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS RECEIPT OF 222239 LOT 1106169: PLATE BI CHROMAGAR ORIENT/TSA II SB 100 WITH VISIBLE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407671 ↗
• MalfunctionAug 30, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING 230 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATE¿ 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: " CUSTOMER REPORTS RECEIPT OF CONTAMINATED PLATES FOR ITEM 222239 LOT 1099123 - PLATE BI CHROMAGAR ORIENT/TSA II SB."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388887 ↗
• MalfunctionAug 11, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ 2 WITH CONTAMINATION AND 23 PHYSICAL DEFECTS WERE OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THERE ARE DISCOLORATION, FILL VOLUME AND CRACKED MEDIA. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310664 ↗
• MalfunctionAug 6, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATE¿ 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: " IT WAS REPORTED THAT REPORTED CONTAMINATION. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292027 ↗
• MalfunctionAug 5, 2021Contamination; Contamination

  IT WAS REPORTED THAT 12 PLATES OF BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CONTAMINATION LOT 1154814. CUSTOMER REPORTED BOXES WERE IN GOOD CONDITION AND STARTED NOTICING CONTAMINATION THIS WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284470 ↗
• MalfunctionAug 5, 2021Contamination; Contamination

  IT WAS REPORTED THAT 5 PLATES OF BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ WERE DISCOVERED TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTS CONTAMINATED PLATES FOR CAT 222239 LOT 1152672.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283020 ↗
• MalfunctionAug 3, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT WHILE USING 6 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATE MISSING LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER REPORTS RECEIVING 6 222239 PLATES THAT HAD NO PLATE STAMP ON THEM FOR IDENTIFICATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271301 ↗
• MalfunctionJul 29, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ 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: "THE PETRI DISH WAS DAMAGED. INCOMPLETE MEDIA FILLING.THE MEDIUM HAS BEEN CONTAMINATED LOT 10991231106174: INCOMPLETE MEDIA FILLING. THE MEDIUM HAS BEEN CONTAMINATED AND DISCOLOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250288 ↗
• MalfunctionJul 29, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ 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: " 1. INCOMPLETE MEDIA FILLING. 2. THE MEDIUM HAS BEEN CONTAMINATED AND DISCOLOR. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250116 ↗
• MalfunctionJul 15, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING 30 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATE¿ 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: " LOT 1085486: THE MEDIUM HAS BEEN CONTAMINATED LOT 1099123: THE MEDIUM HAS BEEN CONTAMINATED AND DISCOLOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178043 ↗
• MalfunctionJul 13, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO USE WITH 40 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ PLATES WERE DISCOVERED TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLATES CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163277 ↗
• MalfunctionJul 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 10 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATES¿ 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: "THE MEDIUM HAS BEEN CONTAMINATED BEFORE BEING USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125046 ↗
• MalfunctionJul 6, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO USE WITH 20 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿CONTAMINATION WAS DISCOVERED ON THE PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MEDIUM HAS BEEN CONTAMINATED BEFORE BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12123315 ↗