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BD BBL™ Trypticase™ Soy Agar W/5% SB(TSA II) /Mac II Agar 221290Recalls & reported problems

Becton, Dickinson And Company · Plate Tsa II SB//Mac II 20 Ea · Class 1

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 10382902212901), received between Mar 2, 2021 and Aug 11, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Contamination2

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.

  • MalfunctionAug 11, 2021Contamination; Contamination

    IT WAS REPORTED THAT THE MEDIA WAS CONTAMINATED WITH BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING BACTERIAL CONTAMINATION IN MEDIA PRODUCT 221290 LOT 1099128 - PLATE TSA II SB/ MAC II.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12309229 ↗
  • MalfunctionMar 2, 2021Contamination; Contamination

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR CONTAMINATION 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 11401384 ↗

Other CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL devices

All CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.