Seraclone® Anti-S (MNS3) 808052100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969951536), received between Apr 26, 2018 and May 27, 2020 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2020False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH ANTI-S WHEN THE PATIENT HAS A POSITIVE DAT. THE CUSTOMER HAS HAD TWO PATIENTS WHERE GENOTYPE TESTING FROM A REFERENCE LAB INDICATED THAT THEY WERE S NEGATIVE AND USING SERACLONE ANTI-S LOT 8913180-01 THE RESULTS WERE POSITIVE 1+. ONE OF THE PATIENT'S CELLS WERE TREATED WITH EGA (CHEMICAL TREATMENT TO DISASSOCIATE IGG FROM THE CELLS) AND THE TESTING WAS REPEATED. THE REACTION WITH SERACLONE ANTI-S WAS STILL POSITIVE, EVEN STRONGER. THE DATE OF EVENT IS NOT KNOWN. THE CUSTOMER SAID TO SEND IN THE PATIENT SAMPLE AND THE SUPPOSEDLY DEFECTIVE PRODUCT SERACLONE ANTI-S FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR THE MATERIAL. STILL WE ARE NOT IN THE POSITION TO PROVIDE A CONCLUSIVE STATEMENT. THE ROOT CAUSE ANALYSIS IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10091543 ↗
• MalfunctionApr 26, 2018False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF TWO DONOR SEGMENTS WITH A HISTORY OF ANTI-S WHEN TESTED WITH SERACLONE ANTI-S. THE CUSTOMER DID NOT PROVIDE THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE DONOR SEGMENTS THAT HAD CAUSED THE FALSE NEGATIVE RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE FOR POTENCY AND SPECIFICITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE MINIMUM TITER WAS EXCEEDED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-S FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Information

  MAUDE report 7463642 ↗