MiTF MMab Concentrate, 1 mlRecalls & reported problems
Bio Sb, Inc. · Anti-MiTF is cocktail of two mouse monoclonal antibodies derived from cell culture supernatant that are concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 · Class 1
Data updated Oct 16, 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 B502BSB62520), received between May 19, 2025 and May 19, 2025 — 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 16, 2026.
Reports received per month
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 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A CUSTOMER COMPLAINT WAS RECEIVED REGARDING MITF (C5 & D5) ANTIBODY COCKTAIL PERFORMANCE IN IHC STAINING. INTERNAL INVESTIGATION REVEALED THAT CERTAIN LOTS WERE MISSING ONE OF THE LABELED CLONES, WHICH MAY LEAD TO FALSE-NEGATIVE RESULTS. THE PRODUCT LABELING INDICATES THE PRESENCE OF BOTH CLONES C5 AND D5, BUT ONLY ONE WAS CONFIRMED IN THE AFFECTED LOTS. ALTHOUGH NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED, THE POTENTIAL FOR DIAGNOSTIC MISINTERPRETATION EXISTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22041563 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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