BD BBL™ Martin-Lewis Agar 221558Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Martin-Lewis Agar · Class 2
All models of BD BBL Martin-Lewis Agar (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10382902215582), 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).
1 FDA recall record name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K770287); they may or may not involve this specific model.
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.
Recalls naming this device
- Mar 17, 2021Class IITerminated
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 problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K770287. One submission often covers many models, so check the product and lot details in each record.
- Z-1378-2021 · Mar 17, 2021 · TerminatedBD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221557
Other CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA devices
- BD BBL™ Martin-Lewis Agar 221557Becton, Dickinson And Company · CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA1 recall0 reports
- NA R01460Remel, Inc. · Culture Media, For Isolation Of Pathogenic Neisseria1 recall0 reports
- NA R04030Remel, Inc. · Culture Media, For Isolation Of Pathogenic Neisseria1 recall0 reports
- BD BBL™ Modified Thayer-Martin (MTM II) Agar 221568Becton, Dickinson And Company · CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA1 report
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 · each recall links to the FDA recall notice
- 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