Seraclone® Anti-Jka (JK1) 808179100Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07611969951758), received between Sep 16, 2016 and Feb 26, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF SERACLONE ANTI-JKA. THE CUSTOMER STATED THAT SHE TESTED SERACLONE ANTI-JKA WITH THREE DIFFERENT HETEROZYGOUS RED BLOOD CELLS: ONE REACTED WEAK POSITIVE, ONE WAS NEGATIVE TO WEAK AND THE THIRD RED BLOOD CELL SHOWED A FALSE NEGATIVE REACTION. THE CUSTOMER RETURNED A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT BUT NOT THE RED BLOOD CELL THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT MATERIAL AS WELL AS THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR POTENCY AND SPECIFICITY. THE TESTING WAS PERFORMED IN PARALLEL WITH A REFERENCE LOT. ALL REAGENT SAMPLES SHOWED COMPARABLE RESULTS AND EXCEEDED THE MINIMUM TITER. WITHIN THE TESTING FOR SPECIFICITY THE PRODUCT SAMPLE RETURNED BY THE CUSTOMER, THE RETENTION SAMPLE, AND A REFERENCE WERE TESTED WITH DIFFERENT SAMPLES FOR SPECIFICITY. AGAIN, ALL THREE REAGENTS SHOWED COMPARABLE RESULTS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. THE POSITIVE REACTIONS WERE STRONGLY POSITIVE (4+). WE DID NOT OBSERVE ANY FALSE NEGATIVE OR WEAKENED REACTION. THE TESTING WAS DONE ACCORDING TO THE INSTRUCTION FOR USE (IFU): TUBE TEST WITH AN INCUB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778201 ↗
• MalfunctionJan 24, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT SERACLONE ANTI-JK(A) SHOWED FALSE NEGATIVE RESULTS WITH THE CONTROL. THE CUSTOMER USED JK(A) POSITIVE RED BLOOD CELLS OF BIOTESTCELL-I11 AS POSITIVE CONTROL. THE CUSTOMER STATED THAT CELL #1 AND #5 OF BIOTESTCELL-I11 YIELDED FALSE NEGATIVE REACTIONS. THE CUSTOMER ANNOUNCED TO SEND IN THE AFFECTED PRODUCT FOR INVESTIGATIONAL TESTING, OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR THE COMPLAINT SAMPLE. IN THE MEANTIME, THEY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR POTENCY AND SPECIFICITY. THE MINIMUM TITER OF 8 WAS EXCEEDED. THE SPECIFICITY TESTING WAS PERFORMED WITH BIOTESTCELL-I11. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT ACCORDING TO THE ANTIGEN TABLE. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. CELL #1 AND #5 OF BIOTESTCELL-I11 SHOWED CORRECTLY POSITIVE RESULTS. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13333706 ↗
• MalfunctionDec 16, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT SERACLONE ANTI-JK(A) DID NOT REACT AS EXPECTED. THE CUSTOMER OBSERVED THIS ISSUE WITH ONE PATIENT SAMPLE. THE REAGENT HAD BEEN WORKING FINE UNTIL THEY HAD ONE PATIENT REACT NEGATIVE WITH ANTI-JKA (HETEROZYGOUS CONTROL REACTED 1+ WEAK). REPEAT TESTING USING ANOTHER VIAL OF SAME LOT OF ANTI-JKA GOT THE PATIENT REACTING WEAK AND THE CONTROL 2+ (DIFFERENT CONTROL CELL USED). THE CUSTOMER USED TWO DROPS OF ANTISERA, INCUBATED FOR 30 MINUTES AT ROOM TEMPERATURE (20-24C), SPUN FOR 20 SECONDS AT 3500 RPM. THE CUSTOMER DID NOT PROVIDE A DATE OF EVENT. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE AND ALSO THE PATIENT SAMPLE THAT CAUSED A FALSE NEGATIVE TEST RESULT FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE FOR POTENCY AND SPECIFICITY IN PARALLEL WITH THEIR RETENTION SAMPLE AND A REFERENCE LOT. THE MINIMUM TITER OF 8 WAS EXCEEDED. ALL THREE REAGENTS (COMPLAINT SAMPLE, RETENTION SAMPLE AND REFERENCE LOT) SHOWED COMPARABLE RESULTS. FURTHERMORE, THE PATIENT SAMPLE WAS TESTED WITH THE COMPLAINT SAMPLE, THE RETENTION SAMPLE, AND THE REFERENCE LOT. THE TESTING WAS DONE WITH AN INCUBATION FOR 15 MINUTES AND FOR 30 MINUTES AT ROOM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13016070 ↗
• MalfunctionApr 5, 2019False Negative Result; Compatibility Problem

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A DONOR UNIT WHEN TESTED WITH SERACLONE ANTI-JK(A). THE CUSTOMER STATED THAT SHE HAD TO CROSSMATCH A PATIENT WITH A KNOWN ANTI-JK(A). THE DONOR UNIT WAS TYPED FOR JK(A) USING SERACLONE ANTI-JK(A). THE DONOR UNIT YIELDED A NEGATIVE REACTION. BASED ON THIS NEGATIVE REACTION THE DONOR UNIT WAS CROSSMATCHED FOR THE PATIENT. BUT THE CROSSMATCH WAS FOUND TO BE INCOMPATIBLE. THE DONOR UNIT WAS RETESTED INTERNALLY AND EXTERNALLY AND FOUND TO BE JK(A) POSITIVE. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT SERACLONE ANTI-JKA FOR INVESTIGATIONAL TESTING NOR THE DONOR UNIT THAT CAUSED THE FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF SERACLONE ANTI-JKA WITH DIFFERENT DONOR AND REAGENT RED BLOOD CELLS FOR POTENCY AND SPECIFICITY. FOR THE SPECIFICITY TESTING OUR QUALITY CONTROL LABORATORY ALSO USED PANEL CELLS OF A COMPETITOR. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE POTENCY TESTING WAS DONE WITH DONOR RED BLOOD CELLS. THE REQUIRED MINIMUM TITER OF 8 WAS EXCEEDED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFI

  Patient problems: Test Result

  MAUDE report 8486009 ↗
• MalfunctionJul 10, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WHEN TESTED WITH SERACLONE ANTI-JK(A). THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE AS WELL AS THEIR RETENTION SAMPLE OF SERACLONE ANTI-JK(A) WITH THE PATIENT SAMPLE AND YIELDED A POSITIVE RESULT. ADDITIONALLY THE SUPPOSEDLY DEFECTIVE PRODUCT WAS TESTED FOR SPECIFICITY AND POTENCY. ALL ACCEPTANCE CRITERIA WERE MET. THE REQUIRED MINIMUM TITER OF 8 WAS EXCEEDED. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-JK(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. A HANDLINGS FAILURE OF CUSTOMER CANNOT BE EXCLUDED, BECAUSE IN THE TEST PROTOCOLS SUBMITTED BY THE CUSTOMER AN INCUBATION TEMPERATURE OF 37°C IS DOCUMENTED. ACCORDING TO THE INSTRUCTION FOR USE TESTS WITH SERACLONE ANTI-JK(A) HAVE TO BE INCUBATED AT ROOM TEMPERATURE AN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7672674 ↗
• MalfunctionJul 10, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WHEN TESTED WITH SERACLONE ANTI-JK(A). THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE AS WELL AS THEIR RETENTION SAMPLE OF SERACLONE ANTI-JK(A) WITH THE PATIENT SAMPLE AND YIELDED A POSITIVE RESULT. ADDITIONALLY THE SUPPOSEDLY DEFECTIVE PRODUCT WAS TESTED FOR SPECIFICITY AND POTENCY. ALL ACCEPTANCE CRITERIA WERE MET. THE REQUIRED MINIMUM TITER OF 8 WAS EXCEEDED. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-JK(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. A HANDLINGS FAILURE OF CUSTOMER CANNOT BE EXCLUDED, BECAUSE IN THE TEST PROTOCOLS SUBMITTED BY THE CUSTOMER AN INCUBATION TEMPERATURE OF 37°C IS DOCUMENTED. ACCORDING TO THE INSTRUCTION FOR USE TESTS WITH SERACLONE ANTI-JK(A) HAVE TO BE INCUBATED AT ROOM TEMPERATURE AN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7672673 ↗
• MalfunctionJun 5, 2018False Negative Result; Defective Component

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A JK(A) POSITIVE CONTROL WITH SERACLONE ANTI-JK(A). THE CUSTOMER USED THE JK(A) POSITIVE PANEL CELL #3 OF BIOTEST CELL-I11 AS A POSITIVE CONTROL. DESPITE SEVERAL INQUIRIES, THE CUSTOMER WAS NOT ABLE TO PROVIDE A DATE OF EVENT. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT SERACLONE ANTI-JKA FOR INVESTIGATIONAL TESTING BUT HE DID NOT RETURN THE POSITIVE CONTROL. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE RETURNED BY THE CUSTOMER AS WELL AS THEIR RETENTION SAMPLE OF SERACLONE ANTI-JKA WITH DIFFERENT DONOR CELLS 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 AND ALSO THE REAGENT RED BLOOD CELLS OF BIOTEST CELL, E.G. CELL #3 OF BIOTEST CELL-I11. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE REQUIRED MINIMUM TITER OF 8 WAS EXCEEDED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-JK(A) FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE

  Patient problems: No Patient Involvement

  MAUDE report 7568361 ↗
• MalfunctionApr 12, 2018False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF JK(A+) RED BLOOD CELLS WHEN TESTED WITH SERACLONE ANTI-JK(A). THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING BUT NOT THE SPECIMENS THAT CAUSED THE FALSE NEGATIVE REACTIONS. TESTING IN OUR QUALITY CONTROL LABORATORY 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 7424307 ↗
• MalfunctionMar 27, 2018Defective Component

  THE CUSTOMER REPORTED THAT THEY HAD VERY WEAK REACTIONS WITH THE POSITIVE CONTROL WHEN USING OUR BLOOD GROUPING REAGENT SERACLONE ANTI-JKA (JK1), LOT 8642050-01. THEY HAD DISCREPANT RESULTS BETWEEN TWO LOT NUMBERS WITH A DONOR SAMPLE. WITH A "NEW" LOT OF ANTI-JKA (JK1), #8729070-01, THEY GOT A 2+ POS. REACTION AND THE RESULT WITH THE "OLD" (#8642050-01) LOT WAS NEGATIVE. THE BOTTLE WITH THE ALLEGEDLY DEFECTIVE PRODUCT HAD BEEN DISCARDED BY THE CUSTOMER. BUT THE CUSTOMER PROVIDED A PATIENT SAMPLE AND AN ALIQUOT OF THE QUOTIENT PANEL CELL THAT WERE USED FOR TESTING. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES OF BOTH REAGENT LOTS THAT WERE USED ON THE CUSTOMER'S SITE. THE POTENCY WAS CHECKED AS WELL AS THE POSITIVE AND NEGATIVE SPECIFICITY. THE MINIMUM POTENCY OF 1:8 WAS EXCEEDED. THE POSITIVE AND NEGATIVE SPECIFICITY WAS TESTED WITH ERYTHROCYTES FROM DONORS. THE QUOTIENT PANEL CELL WAS ALSO USED AND THE PATIENT SAMPLE SENT IN BY THE CUSTOMER THAT HAD CAUSED DISCREPANT RESULTS. OUR QUALITY CONTROL LABORATORY YIELDED A 4W POSITIVE REACTION WITH THE PATIENT SAMPLE WITH BOTH BATCHES. THE QUOTIENT PANEL CELL WAS USED "WASHED OUT" AND SUSPENDED 5% WITH ISOTONIC SALINE SO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7372687 ↗
• MalfunctionJan 13, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A DONOR UNIT WHEN TESTED WITH SERACLONE ANTI-JK(A). THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING , BUT DID NOT RETURN THE SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE RETURNED PRODUCT SAMPLE IN COMPARISON TO THEIR RETAINED SERACLONE ANTI-JKA SAMPLE WITH DIFFERENT JKA+B+ RED BLOOD CELLS. ALL POSITIVE REACTIONS COULD BE CONFIRMED AS CORRECT, NO FALSE NEGATIVE REACTIONS WERE OBSERVED.. A POTENCY TEST OF THE RETAINED AND THE COMPLAINT SAMPLE SHOWED COMPARABLE RESULTS, BOTH SAMPLES EXCEEDED THE REQUIRED MINIMUM TITER. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-JK(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 6249429 ↗
• MalfunctionSep 16, 2016Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF JK(A) POSITIVE SAMPLES WITH SERACLONE ANTI-JK(A). THE CUSTOMER ALSO REPORTED THAT SHE WAS NOT SURE WHICH REACTIONS WERE POSITIVE RESPECTIVELY NEGATIVE. THE INCIDENTS OCCURED ON (B)(6), FOR WHICH WE FILED A SEPARATE MDR, ON (B)(6) (THIS MDR) AND ALSO SOME DAY DURING "THE LAST WEEK OF (B)(6)". SINCE WE DO NOT KNOW THE EXACT DATE FOR THE EVENT IN JULY, WE REFRAINED FROM FILING A SEPARATE REPORT. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT SERACLONE ANTI-JKA AND ALSO SEVEN PATIENT SAMPLES THAT HAD CAUSED UNCLEAR TEST RESULTS. OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLES WITH THE CUSTOMER'S RETURNED SERACLONE ANTI-JKA SAMPLE AND ALSO WITH THEIR RETAINED PRODUCT SAMPLE. SIX PATIENT SAMPLES SHOWED CLEARLY POSITIVE RESULTS AND ONE SAMPLE REACTED NEGATIVELY. ADDITIONALLY, THE RETURNED AND THE RETAINED SERACLONE ANTI-JKA SAMPLE WERE TESTED WITH DIFFERENT JKA+B+ RED BLOOD CELLS. ALL POSITIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE POTENCY OF THE RETAINED AND THE COMPLAINT SAMPLE WERE ALSO TESTED. THE REQUIRED MINIMUM TITER WAS EXCEEDED. COMPLAINT AND RETAINED SAMPLE SHOWED COMPARABLE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5955221 ↗
• MalfunctionSep 16, 2016False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF JK(A) POSITIVE SAMPLES WITH SERACLONE ANTI-JK(A). THE CUSTOMER ALSO REPORTED THAT SHE WAS NOT SURE WHICH REACTIONS WERE POSITIVE RESPECTIVELY NEGATIVE. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT SERACLONE ANTI-JKA AND ALSO SEVEN PATIENT SAMPLES THAT HAD CAUSED UNCLEAR TEST RESULTS. OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLES WITH THE CUSTOMER'S RETURNED SERACLONE ANTI-JKA SAMPLE AND ALSO WITH THEIR RETAINED PRODUCT SAMPLE. SIX PATIENT SAMPLES SHOWED CLEARLY POSITIVE RESULTS AND ONE SAMPLE REACTED NEGATIVELY. ADDITIONALLY, THE RETURNED AND THE RETAINED SERACLONE ANTI-JKA SAMPLE WERE TESTED WITH DIFFERENT JKA+B+ RED BLOOD CELLS. ALL POSITIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE POTENCY OF THE RETAINED AND THE COMPLAINT SAMPLE WERE ALSO TESTED. THE REQUIRED MINIMUM TITER WAS EXCEEDED. COMPLAINT AND RETAINED SAMPLE SHOWED COMPARABLE RESULTS IN ALL TESTS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-JK(A) FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5955220 ↗