BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) 221261Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II), Carton of 100 plates · Class 1
Quick summary
This BD BBL Trypticase Soy Agar with 5% Sheep Blood is a laboratory culture plate used to grow bacteria from patient samples. Most of the 52 reports describe lab results that were wrong or hard to read, or problems with the plate labeling, and a few describe contamination growing on or beneath the agar. No deaths or injuries were reported. One recall, started in October 2018 and closed, involved a single lot made with mixed-up materials that inhibited growth of Gram negative organisms.
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
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10382902212611), received between Mar 23, 2022 and Aug 25, 2026 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (31 reports).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Oct 22, 2018Terminated
a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.
Z-0528-2019 · Root cause: Mixed-up of materials/components · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings31
- Device Markings/Labelling Problem17
- Contamination3
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50436341 ↗MalfunctionJan 20, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) FOR PATIENT SAMPLE, THE CUSTOMER NOTICED CONTAMINATION WAS GROWING BENEATH THE AGAR. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115297 ↗MalfunctionDec 4, 2025Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BEFORE AND WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE CONTAMINATED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717779 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 15 OF 15 IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466780 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 13 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466242 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 14 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466241 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 11OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465927 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 12 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465918 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 10 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465558 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 8 OF 15 IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465557 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 9 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465556 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 6 OF 15 IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465418 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 4 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465083 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 7 OF 15: IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465079 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23464865 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 5 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23464864 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 3 OF 15. IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23464862 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 15 IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THE USER NOTICED CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23464473 ↗MalfunctionOct 24, 2025Contamination; Contamination
IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), AN UNSPECIFIED NUMBER OF PATIENTS SAMPLES WERE CONTAMINATED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379523 ↗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¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), 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 22844033 ↗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¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), 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 22843037 ↗MalfunctionAug 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II), EXCESSIVE MOISTURE WAS PRESENT. THE USER ALLEGED THE EXCESSIVE MOISTURE LED TO CONTAMINATION AND A PATIENT RECEIVING AN ANTIBIOTIC DUE TO A BACILLUS SPECIES (NOT ANTHRACIS) IDENTIFIED FROM CULTURE. IT WAS NOTED THAT THE USER RARELY IDENTIFIED BACILLUS SPECIES (NOT ANTHRACIS) FROM THIS AGAR PLATE. CONFIRMATORY TESTING INCLUDED GRAM STAIN, SUBCULTURE, VITEK 2, AND MALDI-TOF. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750878 ↗MalfunctionJul 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II), THERE WAS A POTENTIAL FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22577160 ↗MalfunctionApr 25, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THAT AN UNSPECIFIED NUMBER OF SLEEVES WERE MISSING THE PRODUCT LABEL. THE LABELS WERE FOUND AFFIXED IN DUPLICATE TO OTHER SLEEVES IN OTHER PACKAGED CASES OF SHIPPED MEDIA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21910074 ↗MalfunctionApr 23, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THAT ONE (1) SLEEVE OF MEDIA WAS MISSING THE PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21894445 ↗
Other CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL devices
- BD BBL™ Enriched Thioglycollate Medium 221788Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL160 reports
- BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood and MacConkey II Agar I Plate™ 221291Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL106 reports
- BD BBL™ CDC Anaerobe 5% Sheep Blood Agar 221734Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL63 reports
- BD BBL™ Fluid Thioglycollate Medium 221196Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL1 recall4 reports
- BD BBL™ Trypticase™ Soy Broth 221716Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL31 reports
- BD BBL™ Trypticase™ Soy Broth 297354Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL27 reports
- BD BBL™ Trypticase™ Soy Agar (Soybean-Casein Digest Agar) 221283Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL19 reports
- BD BBL™ Enriched Thioglycollate Medium 221742Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL18 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.