BD BBL Martin-Lewis AgarRecalls & reported problems across all models

We found 2 models of BD BBL Martin-Lewis Agar by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Aug 11, 2021 and Aug 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BD BBL Martin-Lewis Agar recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 17, 2021Terminated

   Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment

   Z-1378-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Mar 17, 2021Terminated

   Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment

   Z-1377-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported BD BBL Martin-Lewis Agar problems

BD BBL Martin-Lewis Agar models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD BBL™ Martin-Lewis Agar 221558

  CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
  1 recall1 report
• BD BBL™ Martin-Lewis Agar 221557

  CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
  1 recall0 reports

Recent BD BBL Martin-Lewis Agar adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ MARTIN-LEWIS AGAR ATYPICAL GROWTH 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 THERE ARE "POOR RESULTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310853 ↗

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