BD BBL™ Trypticase™ Soy Agar Modified (TSA II) Deeps 297941Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Trypticase™ Soy Agar Modified (TSA II) Deeps · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30382902979419), received between Oct 13, 2022 and Feb 8, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR, MODIFIED (TSA II), DEEPS TWO FAILED TESTS FROM LOW CFU RECOVERY WHEN USING PRODUCT 297941, LOT 2301029. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING TWO FAILED TESTS FROM LOW CFU RECOVERY WHEN USING PRODUCT 297941, LOT 2301029.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16318646 ↗MalfunctionOct 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR, MODIFIED (TSA II), DEEPS THERE WAS CONTAMINATION. ID TESTING WAS CONDUCTED AND BACILLUS FLEXUS WAS IDENTIFIED IN (1) ONE IN-PROCESS SAMPLE PLATE THAT HAD TSA FLUID ADDED TO IT, (2) THE NEGATIVE CONTROL PLATE WITH ONLY THE TSA FLUID, AND (3) THE TSA TUBE USED FOR TESTING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION FOR CAT 297941 LOT 2089931. -STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: PER SCAR, CUSTOMER REPORTS THAT DURING QC MICROBIOLOGY TESTING UTILIZING LOT 2089931, A NEGATIVE SAMPLE TESTED OOS FOR BIOBURDEN PER LAB INVESTIGATION REC 591173. AN ASSOCIATED TSA TUBE WAS OBSERVED WITH GROWTH, AND ID TESTING WAS CONDUCTED. AN ENDOSPORE BACTERIAL ORGANISM, BACILLUS FLEXUS, WAS IDENTIFIED IN (1) ONE IN-PROCESS SAMPLE PLATE THAT HAD TSA FLUID ADDED TO IT, (2) THE NEGATIVE CONTROL PLATE WITH ONLY THE TSA FLUID, AND (3) THE TSA TUBE USED FOR TESTING. THE LABORATORY INVESTIGATION INDICATES THE TSA TUBE AS A POTENTIAL SOURCE OF THE CONTAMINATION. 2,015 TUBES REMAINING FROM THE SUPPLIER LOT ARE CURRENTLY BEING HELD DUE TO THIS CONCERN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15602273 ↗
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™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) 221261Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL1 recall51 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page