Seraclone® Anti-K (KEL1) 808090100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07611969951574), received between Nov 14, 2016 and Feb 17, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026False Negative Result

  THE CUSTOMER REPORTED WEAK AND APPARENTLY FALSE NEGATIVE TEST RESULTS WITH SERACLONE ANTI-K WITH DONOR UNITS WHEN INCUBATED AT ROOM TEMPERATURE FOR 5 MINUTES. WHEN TESTS WERE REPEATED WITH WASHED RED CELLS AND THE INCUBATION TIME INCREASED TO 10 MINUTES AT ROOM TEMPERATURE, THE REACTIONS WERE 1 POSITIVE. QC WAS PASSED WITH HETEROZYGOUS K POSITIVE CELLS. THE CUSTOMER DID NOT PROVIDE PATIENT SAMPLES THAT HAD CAUSED THE WEAK OR NEGATIVE REACTIONS NOR A PRODUCT SAMPLE OF SERACLONE ANTI-K FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES PER THE IFU. THE POTENCY (TITER MORE OR EQUAL 1:512) MET BATCH RELEASE ACCEPTANCE CRITERIA; POSITIVE SPECIFICITY WAS CONFIRMED (WITH K+K+ CELLS); NEGATIVE SPECIFICITY WAS CONFIRMED WITH K-K+ CELLS, ALL NEGATIVE. THE REPORTED ISSUE COULD NOT BE REPRODUCED INTERNALLY. THE MANUFACTURING AND QC RECORD REVIEWS SHOWED NO DEVIATIONS THAT COULD HAVE IMPACTED THE QUALITY OF THE PRODUCT. THE CUSTOMER'S QC PASSED, AND A 3+ REACTION WAS OBTAINED WITH A POSITIVE HETEROZYGOUS K PANEL CELL, SUPPORTING THAT THERE IS NO PRODUCT QC INVOLVEMENT. DONOR PHENOTYPE PROFILES WERE NOT AVAILABLE FROM THE CUSTOMER; THE IFU INDIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363224 ↗
• MalfunctionMar 22, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH SERACLONE ANTI-K AND KELL POSITIVE REAGENT RED BLOOD CELLS. HER PERFORMED THE QC TESTING USING CELL I OF IH-CELLS I-II-III, LOT 9302011 (REF 814030100) AS THE POSITIVE CONTROL.FOLLOWING THE IFU THERE WAS NO REACTION WITH K POSITIVE AND K NEGATIVE CELLS IN THE PANEL. THE CUSTOMER RETURNED A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT SERACLONE ANTI-K FOR INVESTIGATIONAL TESTING AND ALSO THE IH-CELL I-II-III WHICH CAUSED THE FALSE NEGATIVE REACTION. AT THE TIME WE RECEIVED THE MATERIAL ON OUR PREMISES, THE CELLS IH-CELL I-II-III WERE ALREADY EXPIRED. OUR QUALITY CONTROL LABORATORY TESTED THE PRODUCT SAMPLE RETURNED BY THE CUSTOMER IN PARALLEL WITH THEIR RETENTION SAMPLE AND THE REFERENCE LOT FOR POTENCY AND SPECIFICITY. DIFFERENT DONOR SAMPLES WERE USED FOR THESE TESTS. THE TESTING WAS PERFORMED ACCORDING TO THE METHOD DESCRIBED IN THE INSTRUCTION FOR USE (IFU): TUBE TEST WITH AN INCUBATION FOR 5 MINUTES AT ROOM TEMPERATURE AND A CENTRIFUGATION FOR 20 SECONDS AT 800-1000 X G; THEN THE RED BLOOD CELL BUTTONS WERE GENTLY DISLODGED, AND THE REACTIONS RATED. ALL ACCEPTANCE CRITERIA WERE MET. THE MINIMUM TITER OF 16 WAS EXCEEDED. THE POSITI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589733 ↗
• MalfunctionDec 16, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH SERACLONE ANTI-K. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL (QC) LABORATORY TESTED THE COMPLAINT SAMPLE WITH DIFFERENT DONOR SAMPLES AND CONFIRMED THE CUSTOMER´S FINDING. THE CUSTOMER'S COMPLAINT SAMPLE WAS TESTED IN PARALLEL WITH THE RETENTION SAMPLE OF OUR QC AND A REFERENCE LOT. BOTH, THE RETENTION SAMPLE OF THE AFFECTED LOT AS WELL AS THE REFERENCE LOT, SHOWED CORRECT RESULTS. THE COMPLAINT SAMPLE WAS ALSO VISUALLY EXAMINATED: THE COMPLAINT SAMPLE SHOWED NEITHER TURBIDITY NOR IMPURITIES AND LOOKED LIKE THE QC RETENTION SAMPLE. ADDITIONALLY, THE COMPLAINT SAMPLE WAS TESTED FOR POTENCY IN PARALLEL WITH OUR QC'S RETAINED SAMPLE AND THE REFERENCE LOT. THE COMPLAINT SAMPLE SHOWED TWO TITER STEPS LESS THAN THE QC RETAINTED SAMPLE AND THE REFERENCE SAMPLE. THEORETICALLY, A CONTAMINATION WITH ANTI-K, ANTI-KPB, ANTI-JSB OR ANTI-LU(B) COULD HAVE CAUSED THE POSITIVE REACTIONS IN THE COMPLAINT SAMPLE. THEREFORE, OUR QC LAB TESTED THE COMPLAINT SAMPLE WITH A FROZEN SAMPLE OF A KELL ZERO DONOR THAT WAS K, KP(B) AND JS(B) NEGATIVE. THE COMPLAINT SAMPLE SHOWED COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13016376 ↗
• MalfunctionDec 16, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH SERACLONE ANTI-K. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL (QC) LABORATORY TESTED THE COMPLAINT SAMPLE WITH DIFFERENT DONOR SAMPLES AND CONFIRMED THE CUSTOMER´S FINDING. THE CUSTOMER'S COMPLAINT SAMPLE WAS TESTED IN PARALLEL WITH THE RETENTION SAMPLE OF OUR QC AND A REFERENCE LOT. BOTH, THE RETENTION SAMPLE OF THE AFFECTED LOT AS WELL AS THE REFERENCE LOT, SHOWED CORRECT RESULTS. THE COMPLAINT SAMPLE WAS ALSO VISUALLY EXAMINED: THE COMPLAINT SAMPLE SHOWED NEITHER TURBIDITY NOR IMPURITIES AND LOOKED LIKE THE QC RETENTION SAMPLE. ADDITIONALLY, THE COMPLAINT SAMPLE WAS TESTED FOR POTENCY IN PARALLEL WITH OUR QC'S RETAINED SAMPLE AND THE REFERENCE LOT. THE COMPLAINT SAMPLE SHOWED TWO TITER STEPS LESS THAN THE QC RETAINED SAMPLE AND THE REFERENCE SAMPLE. THEORETICALLY, A CONTAMINATION WITH ANTI-K, ANTI-KPB, ANTI-JSB OR ANTI-LU(B) COULD HAVE CAUSED THE POSITIVE REACTIONS IN THE COMPLAINT SAMPLE. THEREFORE, OUR QC LAB TESTED THE COMPLAINT SAMPLE WITH A FROZEN SAMPLE OF A KELL ZERO DONOR THAT WAS K, KP(B) AND JS(B) NEGATIVE. THE COMPLAINT SAMPLE SHOWED COMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13016373 ↗
• MalfunctionOct 20, 2020False Negative Result; Output Problem; False Negative Result; Output Problem

  THE CUSTOMER REPORTED WEAKENED POSITIVE AND FALSE NEGATIVE REACTIONS WITH SERACLONE ANTI-K (REF #808090100, LOT #8005050-01). THE CUSTOMER SUBMITTED HER TWO VIALS SERACLONE ANTI-K AND THE PANEL CELL THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. OUR QUALITY CONTROL LABORATORY TESTED SERACLONE ANTI-K FOR POTENCY AND SPECIFICITY. TEST METHOD FOR POTENCY AND POSITIVE SPECIFICITY: INCUBATION FOR 5 MINUTES AT ROOM TEMPERATURE, CENTRIFUGATION FOR 20 SECONDS AT 823 X G. TEST METHOD FOR NEGATIVE SPECIFICITY: INCUBATION FOR 5 MINUTES AND 60 MINUTES AT ROOM TEMPERATURE AND 60 MINUTES AT 37 °C WITH SUBSEQUENT CENTRIFUGATION. WITHIN THE POTENCY TESTING THE COMPLAINT SAMPLES (BOTH VIALS) WERE TESTED IN PARALLEL WITH OUR QUALITY CONTROL LAB'S RETENTION SAMPLE AND A REFERENCE LOT (LOT #8013040-01). THE MINIMUM TITER OF 16 WAS EXCEEDED BY ALL VIALS. FOR THE SPECIFICITY TESTING WE USED THE IMMUCOR PANEL CELL PROVIDED BY THE CUSTOMER, HETEROZYGOUS CELLS OF BIOTESTCELL (BIOTESTCELL P LOT #2041011-00 AND CELL #2 OF BIOTESTCELL-I11 LOT #8041011-00) AND CELL #7 OF PANOCELL 10 (LOT #35435). ALL REAGENT RED BLOOD CELLS YIELDED CORRECTLY POSITIVE RESULTS. BASED ON OUR TEST RESULTS WE CANNOT CONFIRM THE CUSTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10704820 ↗
• MalfunctionJan 11, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A DONOR UNIT WHEN TESTED WITH SERACLONE ANTI-K. THE CUSTOMER DETECTED THE MISTYPING WHEN THE DONOR WAS RE-TESTED ON (B)(6) 2016 WITH A DIFFERENT LOT OF SERACLONE ANTI-K AND YIELDED A POSITIVE RESULT. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE UNIT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF SERACLONE ANTI-K FOR POSITIVE AND NEGATIVE SPECIFICITY AS WELL AS FOR POTENCY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULTS. THE REQUIRED MINIMUM TITER WAS EXCEEDED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-K 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 6239948 ↗
• MalfunctionDec 2, 2016False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF THE POSITIVE CONTROL WITH SERACLONE ANTI-K. CUSTOMER USED A KELL POSITIVE SCREENING RED BLOOD CELL AS A POSITIVE CONTROL. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING, BUT NOT THE POSITIVE CONTROL. OUR QUALITY CONTROL LABORATORY TESTED THE SERACLONE ANTI-K SAMPLE RETURNED BY THE CUSTOMER IN PARALLEL TO THEIR RETAINED PRODUCT SAMPLE. KELL POSITIVE AND NEGATIVE SCREENING AND PANEL RED BLOOD CELLS AS WELL AS DONOR RED BLOOD CELLS WERE USED FOR POSITIVE AND NEGATIVE SPECIFICITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULTS. BOTH, THE COMPLAINT AND THE RETAINED SAMPLE WERE TESTED FOR POTENCY. THE REQUIRED MINIMUM TITER WAS EXCEEDED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-K 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 6140448 ↗
• MalfunctionNov 14, 2016False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A DONOR UNIT WHEN TESTED WITH SERACLONE ANTI-K. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE UNIT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SERACLONE ANTI-K SAMPLE FOR POSITIVE AND NEGATIVE SPECIFICITY AS WELL AS FOR POTENCY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULTS. THE REQUIRED MINIMUM TITER WAS EXCEEDED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-K 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: Reaction

  MAUDE report 6098916 ↗