Seraclone® Anti-N (MNS2) 808415100Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07611969952052), received between Jan 13, 2017 and Jan 16, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (8 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.

• MalfunctionJan 16, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHEN USING SERACLONE ANTI-N (MNS2) WITH N NEGATIVE ORTHO DIAGNOSTICS RRBCS AS A NEGATIVE CONTROL. THE CUSTOMER STATED THAT THE RESULT WAS 3+ POSITIVE INSTEAD OF NEGATIVE. THE CUSTOMER PROVIDED A PRODUCT SAMPLE OF SERACLONE ANTI-N (MNS2) FOR INVESTIGATIONAL TESTING AND ALSO FOUR ORTHO DIAGNOSTICS REAGENT RED BLOOD CELLS (2 X N ANTIGEN NEGATIVE AND 2 X N ANTIGEN POSITIVE CELLS). DURING OUR COMMUNICATION WITH THE CUSTOMER WE REALIZED THAT THE CUSTOMER WAS NOT WORKING ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CUSTOMER SAID THEY USED THE 0.8% CELLS STRAIGHT FROM THE BOTTLE. SHE SAID THAT SHE WOULD USE ABOUT 3-5 DROPS. DUE TO THE LOWER CELL CONCENTRATION SHE USED SOME MORE DROPS. ACCORDING TO THE IFU ONE DROP (50 L) OF A 3 TO 5% SUSPENSION OF RED BLOOD CELLS IN ISOTONIC SALINE MUST BE USED. BASED ON THE DEVIATION FROM IFU, THE COMPLAINT WAS RECLASSIFIED AS A NON REPORTABLE INCIDENT. STILL, OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE PROVIDED BY THE CUSTOMER AND THEIR RETENTION SAMPLE WITH THE UNWASHED PANEL CELLS OF ORTHO WHICH WAS NOT ACCORDING TO THE IFU AND RECEIVED FALSE POSITIVE RESULTS. THEN OUR QUALITY CONTROL LABO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16173109 ↗
• MalfunctionMay 26, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS WITH SERACLONE ANTI-N. THE CUSTOMER STATED THAT BOTH THE RED BLOOD CELL OF THE COMPETITOR AND A PATIENT SAMPLE WERE AFFECTED. THE CUSTOMER RETURNED BOTH THE COMPLAINT SAMPLE AND THE REAGENT RED BLOOD CELL THAT CAUSED A FALSE POSITIVE TEST RESULT FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE IN PARALLEL WITH THEIR RETENTION SAMPLE AND A REFERENCE LOT FOR POTENCY. ALL THREE REAGENTS EXCEEDED THE MINIMUM TITER OF 4. AFTER THE POTENCY TEST, THE CUSTOMER´S SAMPLE WAS USED UP. THEREFORE, FURTHER TESTING WAS PERFORMED WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THE PH VALUE OF THE SUPPOSEDLY DEFECTIVE LOT WAS MEASURED AND MET THE ACCEPTANCE CRITERIA. FURTHERMORE, THE SUPPOSEDLY DEFECTIVE LOT WAS TESTED FOR SPECIFICITY. FOR NEGATIVE SPECIFICITY, RED BLOOD CELLS WITH THE MMSS ANTIGEN CONSTELLATION WERE PREDOMINANTLY USED. THE TEST WAS PERFORMED IN THE TUBE METHOD WITH AN INCUBATION FOR 60 MINUTES AT ROOM TEMPERATURE. WE USED DONOR SAMPLES AS WELL AS BIOTESTCELL AND PANOCELL. THE DONOR CELLS AND BIOTESTCELL SHOWED CLEARLY NEGATIVE RESULTS. TWO OF THE THREE PANOCELL SAMPLES (THE ONE THE CUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11883112 ↗
• MalfunctionMay 26, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS WITH SERACLONE ANTI-N. THE CUSTOMER STATED THAT BOTH THE RED BLOOD CELL OF THE COMPETITOR AND A PATIENT SAMPLE WERE AFFECTED. THE CUSTOMER RETURNED BOTH THE COMPLAINT SAMPLE AND THE REAGENT RED BLOOD CELL THAT CAUSED A FALSE POSITIVE TEST RESULT FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE IN PARALLEL WITH THEIR RETENTION SAMPLE AND A REFERENCE LOT FOR POTENCY. ALL THREE REAGENTS EXCEEDED THE MINIMUM TITER OF 4. AFTER THE POTENCY TEST, THE CUSTOMER´S SAMPLE WAS USED UP. THEREFORE, FURTHER TESTING WAS PERFORMED WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THE PH VALUE OF THE SUPPOSEDLY DEFECTIVE LOT WAS MEASURED AND MET THE ACCEPTANCE CRITERIA. FURTHERMORE, THE SUPPOSEDLY DEFECTIVE LOT WAS TESTED FOR SPECIFICITY. FOR NEGATIVE SPECIFICITY, RED BLOOD CELLS WITH THE MMSS ANTIGEN CONSTELLATION WERE PREDOMINANTLY USED. THE TEST WAS PERFORMED IN THE TUBE METHOD WITH AN INCUBATION FOR 60 MINUTES AT ROOM TEMPERATURE. WE USED DONOR SAMPLES AS WELL AS BIOTESTCELL AND PANOCELL. THE DONOR CELLS AND BIOTESTCELL SHOWED CLEARLY NEGATIVE RESULTS. TWO OF THE THREE PANOCELL SAMPLES (THE ONE THE CUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882975 ↗
• MalfunctionApr 30, 2019False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS WITH SERACLONE ANTI-N. THE CUSTOMER STATED THAT THEY USED N ANTIGEN NEGATIVE PANEL CELLS FROM BIO-RAD AS A NEGATIVE CONTROL IN THE TUBE METHOD. SERACLONE ANTI-N WAS UNEXPECTED WEAK POSITIVE WITH N NEGATIVE RRBCS (CELL #2 AND #3, PHENOTYPE OF BOTH CELLS WAS MMSS). THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PANEL CELLS THAT HAD CAUSED FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF SERACLONE ANTI-N AND COULD CONFIRM THE CUSTOMER´S FINDING. THE RETENTION SAMPLE YIELDED WEAK (1+) FALSE POSITIVE RESULTS WITH RRBCS OF THE PHENOTYPE MMSS. IN ONE CASE THE RETENTION SAMPLE YIELDED A VERY WEAK (+/-) FALSE POSITIVE RESULT WITH RRBCS OF THE PHENOTYPE MMSS. THE RETENTION SAMPLE WAS ALSO TESTED FOR POTENCY AND SPECIFICITY. THE MINIMUM TITER OF 4 WAS EXCEEDED. THE NEGATIVE SPECIFICITY WAS TESTED WITH DONOR AND PANEL CELLS. ACCORDING TO THE INSTRUCTION FOR USE THE RED BLOOD CELLS WERE WASHED AND SUSPENDED IN ISOTONIC SALINE. THE PH VALUE OF THE REAGENT WAS MEASURED AND MET THE SPECIFICATION. BECAUSE OF THE CONFIRMED COMPLAINT AN INTERNAL QU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8563629 ↗
• MalfunctionJul 25, 2018False Negative Result; Defective Component

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WHEN TESTED WITH SERACLONE ANTI-N. THE PATIENT HAD A HISTORY OF BEING N ANTIGEN POSITIVE. THE CUSTOMER PROVIDED THE SUPPOSEDLY DEFECTIVE PRODUCT SERACLONE ANTI-N FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. THE INVESTIGATION OF 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 Information

  MAUDE report 7717360 ↗
• MalfunctionMar 27, 2018False Positive Result

  THE CUSTOMER STATED THAT WHEN TESTING BLOOD GROUPING REAGENT SERACLONE ANTI-N, THE NEGATIVE CONTROL YIELDED AN UNEXPECTED POSITIVE REACTION. THE CUSTOMER USED ORTHO GEL REAGENT RED CELLS FOR QC. THE CUSTOMER DID NOT PROVIDE THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED SIX DIFFERENT REAGENT RED BLOOD CELLS OF THE ANTIGEN CONSTELLATION MMSS WITH THEIR RETENTION SAMPLE OF SERACLONE ANTI-N. FIVE REAGENT RED BLOOD CELLS YIELDED CORRECTLY NEGATIVE RESULT, BUT ONE REAGENT RED BLOOD CELL SHOWED A WEAKLY (+/-) POSITIVE REACTION. ADDITIONALLY THE RETENTION SAMPLE OF SERACLONE ANTI-N WAS TESTED WITH ADDITIONAL FIVE DONOR SAMPLES (3 X MMSS, MMSS, MMSS). ALL REACTIONS WERE CORRECTLY NEGATIVE. FURTHERMORE PH VALUE WAS MEASURED AND POTENCY WAS TESTED. THE RETENTION SAMPLE MET ALL ACCEPTANCE CRITERIA. DUE TO THE SINGLE VERY WEAK (+/-) FALSE POSITIVE REACTION THE FINDINGS OF THE CUSTOMER WERE CONFIRMED BUT ONLY BY USING REAGENT RED BLOOD CELLS OF THE ANTIGEN CONSTELLATION MMSS. VERY WEAK NONSPECIFIC REACTIONS WITH SERACLONE ANTI-N WERE FOUND IN OUR QC TESTS ONLY IF THE RED CELLS HAD THE PHENOTYPE MMSS, MEANING N ANTIGEN NEGATIVE CELLS

  Patient problems: No Patient Involvement

  MAUDE report 7372705 ↗
• MalfunctionFeb 2, 2018False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE REACTIONS OF N NEGATIVE RED BLOOD CELLS WHEN TESTED WITH SERACLONE ANTI-N. THE CUSTOMER USED N NEGATIVE REAGENT RED BLOOD CELLS OF COMPETITORS AS NEGATIVE CONTROLS FOR SERACLONE ANTI-N. THE CUSTOMER STATED THAT 3 OUT OF 10 NEGATIVE CONTROLS YIELDED WEAK POSITIVE TEST RESULTS. THE CUSTOMER USED ORTHO AND IMMUCOR REAGENT RED BLOOD CELLS FOR QC CELLS. ACCORDING TO HIS DOCUMENTATION THE ANTIGEN CONSTELLATION OF ALL REAGENT RED BLOOD CELLS THAT YIELDED FALSE POSITIVE REACTIONS WAS M+N-S+S-. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO TWO ALIQUOTS OF REAGENT RED BLOOD CELLS: ONE FROM ORTHO AND ONE FROM IMMUCOR. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT PRODUCT SAMPLE RETURNED BY THE CUSTOMER WITH THE CUSTOMER'S REAGENT RED BLOOD CELLS AND YIELDED CORRECT NEGATIVE REACTIONS. IN TOTAL OUR QUALITY CONTROL LABORATORY TESTED SIX DIFFERENT REAGENT RED BLOOD CELLS OF THE ANTIGEN CONSTELLATION M+N-S+S- WITH THE ALLEGEDLY DEFECTIVE PRODUCT SAMPLE AND OUR QC LAB'S RETENTION SAMPLE: FIVE REAGENT RED BLOOD CELLS YIELDED CORRECT NEGATIVE RESULTS, BUT ONE REAGENT RED BLOOD CELL SHOWED A WEAK POSITIVE R

  Patient problems: No Code Available

  MAUDE report 7236624 ↗
• MalfunctionFeb 2, 2018False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE REACTIONS OF N NEGATIVE RED BLOOD CELLS WHEN TESTED WITH SERACLONE ANTI-N. THE CUSTOMER USES N NEGATIVE REAGENT RED BLOOD CELLS OF COMPETITORS AS NEGATIVE CONTROLS FOR SERACLONE ANTI-N. THE CUSTOMER PROVIDED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE REAGENT RED BLOOD CELLS OF TWO COMPETITORS. THE INVESTIGATION IN OUR QUALITY CONTROL LABORATORY IS STILL ON GOING. 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 Code Available

  MAUDE report 7236623 ↗
• MalfunctionFeb 2, 2018False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE REACTIONS OF N NEGATIVE RED BLOOD CELLS WHEN TESTED WITH SERACLONE ANTI-N. THE CUSTOMER USED N NEGATIVE REAGENT RED BLOOD CELLS OF COMPETITORS AS NEGATIVE CONTROLS FOR SERACLONE ANTI-N. THE CUSTOMER STATED THAT 3 OUT OF 10 NEGATIVE CONTROLS YIELDED WEAK POSITIVE TEST RESULTS. THE CUSTOMER USED ORTHO AND IMMUCOR REAGENT RED BLOOD CELLS FOR QC CELLS. ACCORDING TO HIS DOCUMENTATION THE ANTIGEN CONSTELLATION OF ALL REAGENT RED BLOOD CELLS THAT YIELDED FALSE POSITIVE REACTIONS WAS M+N-S+S-. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO TWO ALIQUOTS OF REAGENT RED BLOOD CELLS: ONE FROM ORTHO AND ONE FROM IMMUCOR. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT PRODUCT SAMPLE RETURNED BY THE CUSTOMER WITH THE CUSTOMER'S REAGENT RED BLOOD CELLS AND YIELDED CORRECT NEGATIVE REACTIONS. IN TOTAL OUR QUALITY CONTROL LABORATORY TESTED SIX DIFFERENT REAGENT RED BLOOD CELLS OF THE ANTIGEN CONSTELLATION M+N-S+S- WITH THE ALLEGEDLY DEFECTIVE PRODUCT SAMPLE AND OUR QC LAB'S RETENTION SAMPLE: FIVE REAGENT RED BLOOD CELLS YIELDED CORRECT NEGATIVE RESULTS, BUT ONE REAGENT RED BLOOD CELL SHOWED A WEAK POSITIVE R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7236618 ↗
• MalfunctionOct 17, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A REAGENT RED BLOOD CELL OF A COMPETITOR WHEN TESTING WITH SERACLONE ANTI-N. THE CUSTOMER USED TWO DIFFERENT LOTS OF SERACLONE ANTI-N. THE CUSTOMER PROVIDED THE SUPPOSEDLY DEFECTIVE PRODUCT LOT 8629080-01 AND ALSO THE REAGENT RED BLOOD CELL OF THE COMPETITOR FOR INVESTIGATIONAL TESTING. AT THE TIME OUR QUALITY CONTROL LABORATORY RECEIVED THE REAGENT RED BLOOD CELL IT WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE AS WELL AS THEIR RETENTION SAMPLES OF BOTH AFFECTED LOTS WITH DIFFERENT RED BLOOD CELLS FOR POTENCY AND SPECIFICITY. THE REQUIRED MINIMUM TITER OF 4 WAS EXCEEDED. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-N 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 6953980 ↗
• MalfunctionOct 17, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A REAGENT RED BLOOD CELL OF A COMPETITOR WHEN TESTING WITH SERACLONE ANTI-N. THE CUSTOMER USED TWO DIFFERENT LOTS OF SERACLONE ANTI-N. THE CUSTOMER PROVIDED THE SUPPOSEDLY DEFECTIVE PRODUCT LOT 8629080-01 AND ALSO THE REAGENT RED BLOOD CELL OF THE COMPETITOR FOR INVESTIGATIONAL TESTING. AT THE TIME OUR QUALITY CONTROL LABORATORY RECEIVED THE REAGENT RED BLOOD CELL IT WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE AS WELL AS THEIR RETENTION SAMPLES OF BOTH AFFECTED LOTS WITH DIFFERENT RED BLOOD CELLS FOR POTENCY AND SPECIFICITY. THE REQUIRED MINIMUM TITER OF 4 WAS EXCEEDED. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-N 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 6953977 ↗
• MalfunctionJan 13, 2017Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED A MISTYPING WITH SERACLONE ANTI-N BY USING PANOCELL #1 (THE DONOR CELL IS IDENTIFIED AS MN) FROM IMMUCOR (LOT # 45028). CUSTOMER INFORMED US THAT FALSE NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT AND ALSO THE COMPETITOR'S PRODUCT PANOCELL #1 AT THE TIME THE MATERIAL ARRIVED ON OUR PREMISES, THE PANOCELL WAS ALREADY EXPIRED. OUR QUALITY CONTROL LABORATORY TESTED THE TITER OF THE ALLEGEDLY DEFECTIVE SAMPLE SERACLONE ANTI-N IN PARALLEL TO THEIR RETAINED PRODUCT SAMPLE AND ALSO AGAINST A REFERENCE LOT. THE MINIMUM TITER WAS REACHED AND ALL OTHER REAGENTS SHOWED COMPARABLE TITER AND REACTION STRENGTH. PANOCELL #1 WAS TESTED WITH THREE MONOCLONAL ANTI-N REAGENTS AND SHOWED +/- REACTIONS. TESTING WITH POLYCLONAL ANTI-N SHOWED 3W POSITIVE RESULTS. THE ALLEGEDLY DEFECTIVE MATERIAL, THE RETAINED SAMPLE AND A REFERENCE LOT WAS TESTED WITH POSITIVE REAGENT RED BLOOD CELLS (BIOTESTCELL, IMMUCOR). THE REACTIONS WERE CLEARLY POSITIVE (4+). TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTIONALITY OF THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-N. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6249596 ↗