BD Difco™ Shigella Antiserum Poly Group A S. dysenteriae Serotypes 1–7 228341Recalls & reported problems
Becton, Dickinson And Company · BD Difco™ Shigella Antiserum Poly Group A S. dysenteriae Serotypes 1–7 · Class 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
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382902283416), received between May 25, 2021 and May 25, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- 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.
MalfunctionMay 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD DIFCO¿ SHIGELLA ANTISERUM POLY GROUP A 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 IS NO AGGLUTINATION FOR S. DYSENTERIAE SEROGROUP 3 WHEN USING CAT 228341 LOT 9354479. CUSTOMER PROBLEM: CUSTOMER REPORTS NO AGGLUTINATION FOR S. DYSENTERIAE SEROGROUP 3 WHEN USING CAT 228341 LOT 9354479. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11879165 ↗
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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