Seraclone® Anti-Jkb (JK2) 808184100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969951796), received between Dec 23, 2020 and Sep 8, 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.

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.

• MalfunctionSep 8, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF SERACLONE ANTI-JKB TO OUR DISTRIBUTOR IN SWITZERLAND. THE CUSTOMER CLAIMS TO HAVE PERFORMED INPUT CONTROL OF THE REAGENT IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE POSITIVE CONTROL, USING TEST ERYTHROCYTES WITH HETEROZYGOUS ANTIGEN EXPRESSION (3% ERYTHROCYTE SUSPENSION BIOTESTCELL P3), SHOWED A NEGATIVE RESULT. THE PROCEDURE WAS REPEATED TWICE, AND BOTH TIMES THE POSITIVE CONTROL REMAINED NEGATIVE. FOR THE CONTROL THEY USED BIOTESTCELL-P3. THE CUSTOMER DD NOT PROVIDE A PATIENT SAMPLE OR A PRODUCT SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-JKB FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE ACCORDING TO THE INSTRUCTIONS FOR USE. TESTING SENSITIVITY AND TITERS: THE REPORTED LOT DEMONSTRATED HIGH SENSITIVITY, WITH TITERS EXCEEDING THE MINIMUM REQUIREMENT OF 1:8 ON TESTED JK(A+B+) DONOR SAMPLES. THE RESULTS WERE STRONG AND CONSISTENT WITH EXPECTATIONS. THE REFERENCE DONORS JK(A+B+) SHOWED REACTIVITY WITH TITERS OF 1:64 AND 1:32. TESTING SPECIFICITY: ALL JK(B+) RED CELLS (REFERENCE SAMPLES AND DONOR) REACTED STRONGLY POSITIVE. ALL JK(B-) CELLS REACTED CLEARLY NEGATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993044 ↗
• MalfunctionDec 23, 2020False Negative Result; False Negative Result

  CUSTOMER REPORTED ABOUT FALSE NEGATIVE AND TOO WEAK POSITIVE REACTIONS WITH SERACLONE ANTI-JKB. THE CUSTOMER WAS RUNNING THE POSITIVE CONTROL OF THE SERACLONE ANTI-JKB FUSING MULTIPLE HETEROZYGOUS POSITIVE CELLS AND HE FOUND THE REACTIONS TO BE AMAZINGLY FRAGILE AND WEAK COMPARED TO PREVIOUS LOTS OF SERACLONE ANTI-JKB. THE CUSTOMER DECLARED THAT HE FOLLOWED THE PRODUCT IFU ACCORDING THE DIRECTIONS. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE RED BLOOD CELLS USED AS POSITIVE CONTROL. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF SERACLONE ANTI-JK(B) (REF.#: 808184100, LOT #8937090-01, 2021-05-02) IN PARALLEL WITH LOT #8026020-01. BOTH LOTS WERE TESTED MANUALLY FOR POTENCY AND SPECIFICITY. FOR THE POTENCY AS WELL AS THE POSITIVE SPECIFICITY TESTING THE TESTS WERE INCUBATED FOR 15 MINUTES AT ROOM TEMPERATURE AND SUBSEQUENTLY CENTRIFUGED FOR 60 SECONDS AT 800 TO 1000 X G. THE MINIMUM TITER OF 8 WAS ALWAYS EXCEEDED. FOR THE TESTING OF POSITIVE SPECIFICITY JKA+B+ HETEROZYGOUS REAGENT RED BLOOD CELLS OF BIOTEST CELL AND PANOCELL (IMMUCOR) WERE USED. ALL POSITIVE REACTIONS WERE CORRECT AND STRONGLY POSITIVE. THE REAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11062525 ↗