Todd Hewitt Broth + AntibioticsRecalls & reported problems
Biomerieux SA · selective enrichment broth for the detection of group B streptococci in pregnant women. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026118723), received between Apr 4, 2023 and Apr 4, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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
- False Negative Result1
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.
MalfunctionApr 4, 2023False Negative Result; False Negative Result
INTENDED USE: TODD-HEWITT BROTH + ANTIBIOTICS IS A SELECTIVE ENRICHMENT BROTH FOR THE DETECTION OF GROUP B STREPTOCOCCI IN PREGNANT WOMEN (1, 2, 3, 4). THIS BROTH CAN ALSO BE USED FOR THE ENRICHMENT OF S. AUREUS WITHIN THE SCOPE OF METHICILLIN-RESISTANT S. AUREUS DETECTION. ISSUE DESCRIPTION: A CUSTOMER IN ITALY NOTIFIED BIOMÉRIEUX OF NO GROWTH IN ASSOCIATION WITH TODD HEWITT BROTH + ATB 20T 9ML (REF. (B)(4), LOT. 1009554700, EXP. DATE: 6/20/2023). THE CUSTOMER REPORTED AN ANOMALY IN THE GROWTH OF STREPTOCOCCUS AGALACTIAE AFTER ENRICHMENT IN BROTH WITH (B)(6) ((B)(6)) . IN PARTICULAR, THE CUSTOMER OBSERVED A MASSIVE GROWTH IN GBS AND CNA FROM DIRECT SEEDING OF THE VAGINAL SWAB BEFORE THE BROTH ENRICHMENT PROCEDURE AND THE ABSENCE OF GROWTH OF THE SAME STREPTOCOCCUS AGALACTIAE FROM SEEDING ON GBS AND CNA AFTER BROTH ENRICHMENT. THE LABORATORY PROCEDURE FORESEES BOTH THE DIRECT SEEDING OF VAGINAL AND RECTAL SWABS ON CNA AND GBS AND THE ENRICHMENT IN BROTH, FOLLOWED BY INCUBATION IN A THERMOSTAT FOR 18-24H AND THE SUBSEQUENT SEEDING FROM BROTH AGAIN ON CNA AND GBS. STREPTOCOCCUS AGALACTIAE IDENTIFICATION WAS CONFIRMED WITH VITEK 2 CARD. THE CUSTOMER WAS ABLE TO REPORT BUT THERE WAS DI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16673459 ↗
Other CULTURE MEDIA, SELECTIVE BROTH devices
- REMEL R064810Remel, Inc. · Culture Media, Selective Broth1 recall0 reports
- BD BBL™ Lim Broth 296266Becton, Dickinson And Company · CULTURE MEDIA, SELECTIVE BROTH1 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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