BD Difco™ Haemophilus influenzae Antiserum Type d 227901Recalls & reported problems
Becton, Dickinson And Company · BD Difco™ Haemophilus influenzae Antiserum Type d · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382902279013), received between Mar 5, 2024 and Mar 26, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- False Positive Result3
- Incorrect, Inadequate or Imprecise Result or Readings3
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D THE USER RECEIVED WEAK AGGLUTINATION (FALSE POSITIVE RESULTS) FOR A PATIENT SAMPLE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18982691 ↗MalfunctionMar 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D THE USER RECEIVED WEAK AGGLUTINATION (FALSE POSITIVE RESULTS) FOR A PATIENT SAMPLE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18982688 ↗MalfunctionMar 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D THE USER RECEIVED WEAK AGGLUTINATION (FALSE POSITIVE RESULTS) FOR A PATIENT SAMPLE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18982239 ↗MalfunctionMar 13, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH THE BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 3 OF 3
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18894873 ↗MalfunctionMar 13, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH THE BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18894871 ↗MalfunctionMar 5, 2024False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH THE BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18836171 ↗
Other ANTISERA, ALL TYPES, H. INFLUENZA devices
- VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit MK016The Binding Site Group Limited · Antisera, All Types, H. Influenza1 recall0 reports
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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