Seraclone® Anti-s (MNS4) 808068100Recalls & reported problems
Bio-Rad Medical Diagnostics GmbH · Blood Grouping Reagent Anti-s (MNS4); Seraclone® Human Monoclonal (P3YAN3); for tube test; 2ml
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969951550), received between Jan 30, 2025 and Jan 30, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (2 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 Negative Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH SERACLONE ANTI-S. THE CUSTOMER PERFORMED A LOT-TO-LOT COMPARISON (PLEASE ALSO SEE REPORT 9610824-2025-00002) BETWEEN TWO LOTS OF SERACLONE ANTI-S ON (B)(6) 2024, USING HETEROZYGOTES PANEL CELLS FOR THEIR POSITIVE QC AND THE REACTION STRENGTH WAS 3+ FOR ALL POSITIVE CELLS TESTED. THESE SAME CELLS WERE TESTED AGAIN ON (B)(6) 2024 AND SHOWED WEAK 1+ REACTIONS. USING A NEW PANEL RECEIVED EARLIER IN THE DAY, THE CELL THAT WAS TESTED WITH BOTH LOTS SHOWED NEGATIVE RESULTS. THE CUSTOMER ANNOUNCED TO SEND IN A PRODUCT SAMPLE OF THE AFFECTED LOTS OF SERACLONE-S. SO FAR, THE SAMPLES HAVE NOT ARRIVED ON OUR PREMISES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21272598 ↗MalfunctionJan 30, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH SERACLONE ANTI-S. THE CUSTOMER PERFORMED A LOT-TO-LOT COMPARISON (PLASE ALSO SEE REPORT 9610824-2025-00001) BETWEEN TWO LOTS OF SERACLONE ANTI-S ON (B)(6)2024, USING HETEROZYGOTES PANEL CELLS FOR THEIR POSITIVE QC AND THE REACTION STRENGTH WAS 3+ FOR ALL POSITIVE CELLS TESTED. THESE SAME CELLS WERE TESTED AGAIN ON (B)(6)2024 AND SHOWED WEAK 1+ REACTIONS. USING A NEW PANEL RECEIVED EARLIER IN THE DAY, THE CELL THAT WAS TESTED WITH BOTH LOTS SHOWED NEGATIVE RESULTS. THE CUSTOMER ANNOUNCED TO SEND IN A PRODUCT SAMPLE OF THE AFFECTED LOTS OF SERACLONE-S. SO FAR, THE SAMPLES HAVE NOT ARRIVED ON OUR PREMISES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21272506 ↗
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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