Seraclone® Anti-c (RH4) 802346100Recalls & reported problems
Bio-Rad Medical Diagnostics GmbH · Blood Grouping Reagent Anti-c (RH4); Seraclone® Human Monoclonal (MS33); for tube test; 5ml
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 07611969950461), received between Apr 2, 2024 and Apr 2, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result1
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.
MalfunctionApr 2, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED A FALSE POSITIVE REACTION WITH SERACLONE ANTI-C (RH4). THE CUSTOMER RETURNED A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING. THE RETURNED SAMPLE WAS VISUALLY INSPECTED IN COMPARISON TO THE RETENTION SAMPLES STORED IN OUR QUALITY CONTROL LABORATORY WITH THE LABEL NUMBERS #00002, #00324 AND THE RETENTION SAMPLE WITH THE LABEL NUMBER #00238. A SLIGHT CLOUDINESS AND A MORE INTENSE YELLOWISH COLOR WERE NOTICEABLE IN THE SAMPLE RETURNED BY THE CUSTOMER. ADDITIONALLY, THE COMPLAINT SAMPLE WAS TESTED FOR SPECIFICITY WITH VARIOUS RED BLOOD CELLS AND THE CUSTOMER´S FINDING WAS CONFIRMED. THE COMPLAINT SAMPLE SHOWED UNEXPECTED POSITIVE RESULTS WITH C (RH4) ANTIGEN NEGATIVE RED BLOOD CELLS. FOR FURTHER TESTS, THE RED BLOOD CELLS USED WERE SELECTED IN ORDER TO BE ABLE TO IDENTIFY THE SPECIFICITY OF THE CONTAMINATION OF THE CUSTOMER VIAL. CONTAMINATION WITH SERACLONE ANTI-D AND SERACLONE ANTI-E WAS CLEARLY RULED OUT. BASED ON THE TEST RESULTS THAT ALL C POSITIVE CELLS SHOWED A POSITIVE RESULT, A CONTAMINATION WITH SERACLONE ANTI-C WAS VERY LIKELY. THE RETENTION SAMPLE WAS TESTED FOR SPECIFICITY AND POTENCY AND MET ALL ACCEPTANCE CRITERIA. THE UNEXPECTED FALSE POSITIVE REACTIO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19019628 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page