Seraclone® Anti-Fya (JK1) 808188100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611969951833), received between Jul 18, 2018 and Oct 9, 2018 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2018False Positive Result

  THE CUSTOMER REPORTED FALSE A POSITIVE FY(A) ANTIGEN TYPING RESULT WHEN TESTING WITH SERACLONE ANTI-FY(A). THE CUSTOMER STATED THAT THE DONOR SAMPLE WAS TYPED NEGATIVE WITH IMMUCOR HEA DNA TESTING. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING, BUT HE RETURNED THE DONOR SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR SERACLONE ANTI-FYA RETENTION SAMPLE WITH THE DONOR SAMPLE AND COULD CONFIRM THE CUSTOMER'S FINDING. SUBSEQUENTLY THE DONOR SAMPLE WAS TESTED IN THE DIRECT ANTIGLOBULIN TEST (DAT) AND RECEIVED A POSITIVE RESULT DUE TO A SENSITIZATION WITH IGG. THE IGG ANTIBODY WAS REMOVED FROM THE DONOR RED BLOOD CELLS BY A HEAT ELUTION METHOD, FOLLOWING A RETEST OF THE DONOR SAMPLE WITH THE SUPPOSEDLY DEFECTIVE PRODUCT. NOW THE DONOR SAMPLE REACTED CORRECTLY NEGATIVE. FURTHERMORE THE SUPPOSEDLY DEFECTIVE PRODUCT WAS TESTED FOR POTENCY AND SPECIFICITY. ALL ACCEPTANCE CRITERIA WERE MET. THE MINIMUM TITER OF 16 WAS EXCEEDED. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. THE CAUSE OF THE FALSE POSITIVE RESULT OF THE SPECIFIC DONOR SAMPLE

  Patient problems: Test Result

  MAUDE report 7945954 ↗
• MalfunctionJul 18, 2018False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE FY(A) ANTIGEN TYPING RESULTS WHEN USING SERACLONE ANTI-FY(A). THE CUSTOMER USED VARIOUS FY(A+B+) POSITIVE REAGENT RED BLOOD CELLS FROM TWO DIFFERENT MANUFACTURERS. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE RED BLOOD CELLS THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR AND REAGENT RED BLOOD CELLS FOR POTENCY AND SPECIFICITY. FOR THE SPECIFICITY TESTING OUR QUALITY CONTROL LABORATORY USED SCREENING AND PANEL CELLS OF A COMPETITOR AS WELL AS THE REAGENT RED BLOOD CELLS OF THE BIOTEST CELL PRODUCT LINE. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE REQUIRED MINIMUM TITER OF 16 WAS EXCEEDED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-FY(A) 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 Known Impact Or Consequence To Patient

  MAUDE report 7697407 ↗
• MalfunctionJul 18, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED FALSE NEGATIVE FY(A) ANTIGEN TYPING RESULTS WHEN USING SERACLONE ANTI-FY(A). THE CUSTOMER USED VARIOUS FY(A+B+) POSITIVE REAGENT RED BLOOD CELLS FROM TWO DIFFERENT MANUFACTURERS. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE RED BLOOD CELLS THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR AND REAGENT RED BLOOD CELLS FOR POTENCY AND SPECIFICITY. FOR THE SPECIFICITY TESTING OUR QUALITY CONTROL LABORATORY USED SCREENING AND PANEL CELLS OF A COMPETITOR AS WELL AS THE REAGENT RED BLOOD CELLS OF THE BIOTEST CELL PRODUCT LINE. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE REQUIRED MINIMUM TITER OF 16 WAS EXCEEDED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-FY(A) 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 7697405 ↗