Seraclone® Anti-A,B (ABO3) 801375100Recalls & reported problems
Bio-Rad Medical Diagnostics GmbH · Blood Grouping Reagent Anti-A,B (ABO3); Seraclone® Murine Monoclonal (BS63/BS85); for tube test; 10x10ml
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 07611969950164), received between Jan 13, 2017 and Jan 13, 2017 — 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 Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2017False Negative Result
THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A DONOR SAMPLE WITH SERACLONE ANTI-AB. THE EXACT DATE OF EVENT COULD NOT BE PROVIDED BY THE CUSTOMER BUT OCCURED ACCORDING TO HIM IN (B)(6) 2016. THE CUSTOMER REPORTED THAT TWO DONORS (TWINS) WERE HISTORICALLY TYPED AS BLOOD GROUP O. THE DONOR SAMPLES WERE ALSO TESTED IN A DIFFERENT LABORATORY AND TYPED AS BLOOD GROUP: A SUBGROUP. THE CUSTOMER REPORTED THAT TWIN A (#(B)(6)) REACTED FALSE NEGATIVELY WITH SERACLONE ANTI-AB. THE CUSTOMER DID NOT SEND IN THE ALLEGENDLY DEFECTIVE PRODUCT SERACLONE ANTI-AB FOR INVESTIGATIONAL TESTING BUT HE DID SEND THE TWO DONOR SAMPLES THAT HAD CAUSED THE FALS NEGATIVE TEST RESULT. THEREFOR OUR QUALITY CONTROL LABORATOY TESTED THEIR RETAINED SAMPLE OF SERACLONE ANTI-AB IN PARALLEL TO THE LAST RELEASED LOT (#8630200-03). THE FOLLOWING RESULTS WERE YIELDED WITH DIFFERENT TEST METHODS: DONOR 1 (#(B)(6)): BLOOD GROUP O; DONOR 2 (#(B)(6)): BLOOD GROUP O. FURTHERMORE BOTH DONOR SAMPLES WERE TESTED WITH TWO DIFFERENT DIAMED GEL CARDS (HUMAN AND MONOCLONAL). BOTH SAMPLES REACTED 1W + POSITIVE WITH ANTI-AB MONOCLONAL (CELL LINE: ES-131 (ES-15) + BIRMA-1, ES4). A MOLECULAR GENETIC ANALYSIS WAS CONDUCTED THAT SHO
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6250472 ↗
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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