BD BBL™ Trypticase™ Soy Agar (Soybean-Casein Digest Agar) 221283Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10382902212833), received between Mar 16, 2021 and Oct 8, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK THAT FOUR (4) SLEEVES WERE MISSING THE PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401468 ↗
• MalfunctionSep 19, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK 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 20263974 ↗
• MalfunctionMay 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) THAT THE PH OF THE MEDIA WAS LOWER THAN THE VALUE PROVIDED IN THE CERTIFICATE OF ANALYSIS. THE CUSTOMER OBTAINED A PH RESULT OF 5.8 INSTEAD OF THE ANTICIPATED PH OF 7.3. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234713 ↗
• MalfunctionFeb 23, 2024Missing Information; Missing Information

  IT WAS REPORTED WHILE UNPACKING A CASE OF BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) THAT THERE WAS MIXED PRODUCT. THE CASE CONTAINED BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768618 ↗
• MalfunctionJul 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) THERE WAS BIOLOGICAL CONTAMINATION OF ONE PLATE. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS A CONTAMINATED PLATE. 1 PLATE SO FAR FOUND CONTAMINATED. COLONY IS OFF-WHITE TO BEIGE LOCATED ON THE SURFACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313021 ↗
• MalfunctionApr 17, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT TWO BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) MOLD CONTAMINATION WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MOLD CONTAMINATION ON 2 DISKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16758504 ↗
• 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 (SOYBEAN-CASEIN DIGEST AGAR) FUNGI CONTAMINATION WAS DISCOVERED IN THE 1 CASE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED BIOLOGICAL CONTAMINATION (FUNGI) FOR THE PRODUCT. LOT#2293794. BACTERIA OR FUNGI CONTAMINATION ¿ COLONY COLOR? FUNGI CONTAMINATION. GRAY AND WHITE COLORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318675 ↗
• MalfunctionDec 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) SLEEVE WAS COVERED IN GROWTH UPON OPENING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPENED UP A NEW SLEEVE OF TSA PLATES, ITEM# 221283, LOT# 2270849, AND THERE WAS A PLATE COVERED WITH GROWTH IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16011479 ↗
• MalfunctionDec 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATES WERE SHOWED BACTERIAL GROWTH. NO INJURIES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT FAILED STERILITY TESTING. VISUAL INSPECTION SHOWED SURFACE BACTERIAL GROWTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15972905 ↗
• MalfunctionNov 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES CATALOG 221283 LOT NO. 2189895 IS CONTAMINATED UPON RECEIPT. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845346 ↗
• MalfunctionOct 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) MEDIA IS CONTAMINATED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES MEDIA IS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539546 ↗
• MalfunctionSep 19, 2022Contamination; Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) HAD BIOLOGICAL CONTAMINATION, - BIOLOGICAL, FUNGAL, NON VIABLE. THERE WAS SIX OCCURRENCES IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "CUSTOMER REPORTED THAT THE PRODUCT 221283 HAS MICROBIAL CONTAMINATION. LOT#2819895."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443666 ↗
• MalfunctionDec 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATES WERE CONTAMINATED WITH FUNGUS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT PLATES ARE CONTAMINATED. HOW MANY INDIVIDUAL PLATES HAD OBSERVABLE CONTAMINATION? CUSTOMER STATES ABOUT 50% OF THE PLATES THEY HAVE TESTED SO FAR. THEY CAN NOT PROVIDE AN EXACT COUNT OF AFFECTED PLATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954160 ↗
• MalfunctionNov 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) MOLD WAS DISCOVERED GROWING ON 7 PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTRIBUTOR REPORTED CONTAMINATION OF FUNGUS OR MOLD GROWING ON THE PLATES ON CUSTOMER'S BEHALF. THESE WERE NOT OPENED AS THE CONTAMINATION GROWTH CAN BE SEEN THROUGH THE PLASTIC WRAPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788607 ↗
• MalfunctionAug 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. HERE 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 GROWTH PROMOTION ISSUES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271462 ↗
• MalfunctionJul 29, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) 4 PLATES WERE DISCOVERED TO HAVE FUNGAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING CONTAMINATION WITH 221283 PLATES, LOT 1146024. THE FOUND GROWTH ON 4 PLATES THAT WERE INCUBATED FOR STERILITY VERIFICATION. THE PLATES WERE INCUBATED AT 30-35DEGREES C FOR 5 DAYS. WHEN THE LOT WAS RECEIVED NO ISSUES WHERE VISUALLY NOTICED. MEDIA WAS STORED IN REFRIGERATOR IN SLEEVES UNTIL USE. BACTERIA OR FUNGI? FUNGI ON THE SURFACE OR SUB-SURFACE? SURFACE WAS THE ORGANISM STAINED OR IDENTIFIED?: NO. *WERE ANY ERRANT RESULTS REPORTED DUE TO THE CONTAMINATION?: YES. *WERE ANY PATIENT RESULTS AFFECTED DUE TO THE CONTAMINATION?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249080 ↗
• MalfunctionMay 5, 2021Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT PRIOR TO USE WITH 2 BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) MICROBIAL GROWTH WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT VWR SCAR REPORTED MICROBIAL GROWTH ON 2 PLATES OF SINGLE WRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780755 ↗
• MalfunctionApr 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) 800 PLATES FAILED GROWTH PROMOTION. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT FAILED GROWTH PROMOTION OF PRODUCT 1. QC ORGANISM(S) THAT FAILED TESTING: PSEUDOMONAS AERUGINOSA ATCC 9027 ORGANISM MAINTENANCE: ATCC MICROORGANISM. GROWN ON TSA SLANTS. HARVESTED AND DILUTED AS NECESSARY. 2. INCUBATION WHAT TYPE OF INCUBATOR IS USED (CO2, ETC)?: STANDARD TEMPERATURE- CONTROLLED INCUBATOR. TEMPERATURE OF INCUBATION: 30-35C TIME INCUBATED: 42 HOURS 3. RESULTS WILL RESULTS BE REPORTED AS CFU RECOVERED OR GROWTH/NO GROWTH?: CFU RECOVERED AS PERCENT OF CONTROL COUNT. 4. OTHER HOW LONG HAS THIS MEDIA BEEN IN USE AT THIS FACILITY?: FIRST TIME BD TSA MEDIA USED. THIS BATCH WAS NOT USED FOR ANY RELEASE TESTING. IS THIS THE FIRST TESTING FAILURE?: YES FOR TSA FOR P. AERUGINOSA MULTIPLE OR SINGLE TECHNOLOGIST PERFORMING THIS TEST?: INITIAL TEST: ONE MICROBIOLOGIST, RETEST: TWO DIFFERENT MICROBIOLOGISTS. DO YOU HAVE LOT NUMBERS THAT WORKED IN THE PAST? NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11622072 ↗
• MalfunctionMar 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) FOREIGN MATTER WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490581 ↗