Seraclone® Anti-A (ABO1) 801325100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07611969950065), received between Oct 17, 2014 and Jun 24, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2020False Positive Result; Defective Device

  THE CUSTOMER REPORTED FALSE POSITIVE TEST RESULTS WITH ANTI-A WHEN DONOR SAMPLES WERE TESTED AS A NEGATIVE WITH THE REAGENT OF A COMPETITOR. THE CUSTOMER USED A 4% SUSPENSION OF UNWASHED SEGMENTS AND PERFORMED THE METHOD IMMEDIATE SPIN. THE CUSTOMER DID NOT PROVIDE A DATE OF EVENT. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT AND ONE DONOR SAMPLE THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE DONOR SAMPLE WAS PROVIDED AS THREE SEGMENTS (PIGTAILS) LABELED AS (B)(6). OHR QUALITY CONTROL LABORATORY TESTED THE DONOR SAMPLE WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED A WEAK POSITIVE REACTION. ADDITIONALLY THE COMPLAINT SAMPLE WAS TESTED FOR POTENCY AND SPECIFICITY. ALL ACCEPTANCE CRITERIA WERE MET. THE MINIMUM TITER OF 64 WAS EXCEEDED. BECAUSE THE SEGMENTS DID NOT CONTAIN ANY SERUM OR PLASMA REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WAS NOT POSSIBLE. THEREFORE THE POSSIBLE INFLUENCE OF AN ANTIBODY CAN NOT BE EXCLUDED. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR THE MOLECULAR TYPING THE SEGMENTS COULD NOT BE SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. THE WEAK POS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10188332 ↗
• MalfunctionMay 27, 2020False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH ANTI-A WHEN DONOR SAMPLES WERE TESTED AS A NEGATIVE WITH THE REAGENT OF A COMPETITOR. THE CUSTOMER USED A 4% SUSPENSION OF UNWASHED SEGMENTS AND PERFORMED THE METHOD IMMEDIATE SPIN. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT SERACLONE ANTI-A FOR INVESTIGATIONAL TESTING AND ONE DONOR SAMPLE THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE DONOR SAMPLE WAS PROVIDED AS THREE SEGMENTS (PIGTAILS) LABELED AS (B)(6) . OUR QUALITY CONTROL LABORATORY TESTED THE DONOR SAMPLE WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED A WEAK POSITIVE REACTION. THE COMPLAINT SAMPLE PROVIDED BY THE CUSTOMER WAS TESTED FOR POTENCY AND SPECIFICITY. ALL ACCEPTANCE CRITERIA WERE MET. THE MINIMUM TITER OF 64 WAS EXCEEDED. BECAUSE THE SEGMENTS DID NOT CONTAIN ANY SERUM OR PLASMA REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WERE NOT POSSIBLE. THEREFORE THE POSSIBLE INFLUENCE OF AN ANTIBODY COULD NOT BE EXCLUDED. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR THE MOLECULAR TYPING THE SEGMENTS COULD NOT BE SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10091542 ↗
• MalfunctionMay 27, 2020False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH ANTI-A WHEN DONOR SAMPLES WERE TESTED AS A NEGATIVE WITH THE REAGENT OF A COMPETITOR. THE CUSTOMER USED A 4% SUSPENSION OF UNWASHED SEGMENTS AND PERFORMED THE METHOD IMMEDIATE SPIN. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT SERACLONE ANTI-A FOR INVESTIGATIONAL TESTING AND ONE DONOR SAMPLE THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE DONOR SAMPLE WAS PROVIDED AS THREE SEGMENTS (PIGTAILS) LABELED AS (B)(6) . OUR QUALITY CONTROL LABORATORY TESTED THE DONOR SAMPLE WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED A WEAK POSITIVE REACTION. THE COMPLAINT SAMPLE PROVIDED BY THE CUSTOMER WAS TESTED FOR POTENCY AND SPECIFICITY. ALL ACCEPTANCE CRITERIA WERE MET. THE MINIMUM TITER OF 64 WAS EXCEEDED. BECAUSE THE SEGMENTS DID NOT CONTAIN ANY SERUM OR PLASMA REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WERE NOT POSSIBLE. THEREFORE THE POSSIBLE INFLUENCE OF AN ANTIBODY COULD NOT BE EXCLUDED. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR THE MOLECULAR TYPING THE SEGMENTS COULD NOT BE SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10091538 ↗
• MalfunctionAug 12, 2019False Positive Result; Defective Component; Physical Resistance/Sticking

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF FOUR DONOR UNITS WHEN TESTED WITH SERACLONE ANTI-A. THE CUSTOMER CLAIMED THE UNITS YIELDED BLOOD GROUP AB TEST RESULTS DURING RE-TYPING WHEN THEY WERE LABELLED AS BLOOD GROUP B. THE BLOOD GROUP B OF THE UNITS WAS CONFIRMED BY RE-TESTS USING REAGENTS OF TWO DIFFERENT MANUFACTURERS. THE CUSTOMER RETURNED TWO VIALS FOR THE SUPPOSEDLY DEFECTIVE PRODUCT SERACLONE ANTI-A FOR INVESTIGATIONAL TESTING AND FIVE DONOR SAMPLES (ONE EDTA SAMPLE AND FOUR SEGMENTS). OUR QUALITY CONTROL LABORATORY TESTED BOTH VIALS OF THE SUPPOSEDLY DEFECTIVE PRODUCT RETURNED BY THE CUSTOMER WITH DIFFERENT DONOR SAMPLES FOR POTENCY AND SPECIFICITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. THE MINIMUM TITER OF 64 WAS EXCEEDED. FURTHERMORE THE DONOR SAMPLES (ONE EDTA SAMPLE AND FOUR SEGMENTS) PROVIDED BY THE CUSTOMER WERE TESTED WITH THE VIALS OF THE COMPLAINT SAMPLE. ALL SAMPLES REACTED CLEARLY NEGATIVE EVEN AFTER A PROLONGED INCUBATION TIME OF 60 MINUTES WHICH IS NOT ACCORDING TO THE INSTRUCTION FOR USE. WE ONLY OBSERVED A KIND OF STICKY EFFECT IN THE IMMEDIATE SPIN METHOD AFTER THE CENTRIFUGATION WHEN THE CELL BUTTONS HAD TO BE DISLODGED TO OBSERVE FOR AG

  Patient problems: Reaction

  MAUDE report 8882768 ↗
• MalfunctionNov 18, 2016False Positive Result; Defective Component

  THE CUSTOMER REPORTED THAT TWO DONORS AND ONE PATIENT WERE TYPED AS BLOOD GROUP B, BUT SHOWED WEAK POSITIVE REACTION WITH SERACLONE ANTI-A. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE SAMPLES THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE TWO DONOR SAMPLES WERE PROVIDED AS SEGMENTS (PIGTAILS) (SAMPLE (B)(6)) AND THE PATIENT SAMPLE ((B)(6)) CONSISTED OF RED CELLS IN A TUBE. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR AND PATIENT SAMPLES WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED THE FOLLOWING RESULTS: (B)(6). BECAUSE ALL SAMPLES DID NOT CONTAIN ANY SERUM OR PLASMA, REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WAS NOT POSSIBLE. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR MOLECULAR TYPING, ONLY SAMPLE (B)(6) WAS SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. THE RESULT IS: ABO* B101 / B101. THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE SAMPLE WAS CONFIRMED BY TESTING ITS NEGATIVE AND POSITIVE SPECIFICITY AS WELL AS ITS POTENCY. THE INSTRUCTION FOR USE OF SERACLONE ANTI-A CONTAINS IN THE CHAPTER "SPECIFIC PERFORMANCE CH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6111963 ↗
• MalfunctionNov 18, 2016False Positive Result

  THE CUSTOMER REPORTED THAT TWO DONORS AND ONE PATIENT WERE TYPED AS BLOOD GROUP B, BUT SHOWED WEAKLY POSITIVE REACTION WITH SERACLONE ANTI-A. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT AND ALSO THE SAMPLES THAT HAD CAUSED FALSE POSITIVE REACTIONS. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6111962 ↗
• MalfunctionNov 18, 2016False Positive Result

  THE CUSTOMER REPORTED THAT TWO DONORS AND ONE PATIENT WERE TYPED AS BLOOD GROUP B, BUT SHOWED WEAK POSITIVE REACTION WITH SERACLONE ANTI-A. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE SAMPLES THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE TWO DONOR SAMPLES WERE PROVIDED AS SEGMENTS (PIGTAILS) ((B)(6)) AND THE PATIENT SAMPLE ((B)(6)) CONSISTED OF RED CELLS IN A TUBE. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR AND PATIENT SAMPLES WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED THE FOLLOWING RESULTS: SAMPLE #(B)(6) SHOWED A NEGATIVE REACTION. SAMPLE #(B)(6) SHOWED A POSITIVE REACTION. SAMPLE #(B)(6) SHOWED A NEGATIVE REACTION. BECAUSE ALL SAMPLES DID NOT CONTAIN ANY SERUM OR PLASMA, REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WAS NOT POSSIBLE. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR MOLECULAR TYPING, ONLY SAMPLE #(B)(6) WAS SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. THE RESULT IS: ABO* B101 / B101. THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE SAMPLE WAS CONFIRMED BY TESTING ITS NEGATIVE AND POSITIVE SPECIFICITY A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6111960 ↗
• MalfunctionNov 18, 2016False Positive Result

  THE CUSTOMER REPORTED THAT TWO DONORS AND ONE PATIENT WERE TYPED AS BLOOD GROUP B, BUT SHOWED WEAK POSITIVE REACTIONS WITH SERACLONE ANTI-A. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE SAMPLES THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE TWO DONOR SAMPLES WERE PROVIDED AS SEGMENTS (PIGTAILS) (SAMPLE #(B)(6)) AND THE PATIENT SAMPLE (#A.K.A (B)(4)) CONSISTED OF RED CELLS IN A TUBE. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR AND PATIENT SAMPLES WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED THE FOLLOWING RESULTS: SAMPLE #(B)(4) SHOWED A NEGATIVE REACTION. SAMPLE #(B)(4) SHOWED A POSITIVE REACTION. SAMPLE #A.K.A (B)(4) SHOWED A NEGATIVE REACTION. BECAUSE ALL SAMPLES DID NOT CONTAIN ANY SERUM OR PLASMA, REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WAS NOT POSSIBLE. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR THE MOLECULAR TYPING, ONLY SAMPLE #A.K.A (B)(4) WAS SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. THE RESULT IS: ABO* B101 / B101. THE CORRECT FUNCTION OF THE RETURNED PRODUCT SAMPLE WAS CONFIRMED BY TESTING ITS NEGATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6111959 ↗
• MalfunctionNov 18, 2016False Positive Result

  THE CUSTOMER REPORTED THAT TWO DONORS AND ONE PATIENT WERE TYPED AS BLOOD GROUP B, BUT SHOWED WEAK POSITIVE REACTIONS WITH SERACLONE ANTI-A. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE SAMPLES THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE TWO DONOR SAMPLES WERE PROVIDED AS SEGMENTS (PIGTAILS) (SAMPLE #(B)(4)) AND THE PATIENT SAMPLE (#A.K.A (B)(4)) CONSISTED OF RED CELLS IN A TUBE. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR AND PATIENT SAMPLES WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED THE FOLLOWING RESULTS: SAMPLE #(B)(4) SHOWED A NEGATIVE REACTION. SAMPLE #(B)(4) SHOWED A POSITIVE REACTION. SAMPLE #A.K.A (B)(4) SHOWED A NEGATIVE REACTION. BECAUSE ALL SAMPLES DID NOT CONTAIN ANY SERUM OR PLASMA, REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WAS NOT POSSIBLE. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR THE MOLECULAR TYPING, ONLY SAMPLE #A.K.A (B)(4) WAS SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. THE RESULT IS: ABO* B101 / B101. THE CORRECT FUNCTION OF THE RETURNED PRODUCT SAMPLE WAS CONFIRMED BY TESTING ITS NEGATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6111957 ↗
• MalfunctionNov 18, 2016False Positive Result

  THE CUSTOMER REPORTED THAT TWO DONORS AND ONE PATIENT WERE TYPED AS BLOOD GROUP B, BUT SHOWED WEAK POSITIVE REACTIONS WITH SERACLONE ANTI-A. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE SAMPLES THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE TWO DONOR SAMPLES WERE PROVIDED AS SEGMENTS (PIGTAILS) (SAMPLE #(B)(6) AND SAMPLE #(B)(6)) AND THE PATIENT SAMPLE (#(B)(6)) CONSISTED OF RED CELLS IN A TUBE. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR AND PATIENT SAMPLES WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED THE FOLLOWING RESULTS: SAMPLE #(B)(6) SHOWED A NEGATIVE REACTION. SAMPLE #(B)(6) SHOWED A POSITIVE REACTION. SAMPLE #(B)(6) SHOWED A NEGATIVE REACTION. BECAUSE ALL SAMPLES DID NOT CONTAIN ANY SERUM OR PLASMA, REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WAS NOT POSSIBLE. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR THE MOLECULAR TYPING, ONLY SAMPLE #(B)(6) WAS SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. THE RESULT IS: (B)(6). THE CORRECT FUNCTION OF THE RETURNED PRODUCT SAMPLE WAS CONFIRMED BY TESTING ITS NEGATIVE AND PO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6111943 ↗
• MalfunctionNov 18, 2016False Positive Result

  THE CUSTOMER REPORTED THAT TWO DONOR SAMPLES AND ONE PATIENT SAMPLE WERE TYPED AS BLOOD GROUP B, BUT SHOWED WEAK POSITIVE REACTIONS WITH SERACLONE ANTI-A. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE SAMPLES THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE TWO DONOR SAMPLES WERE PROVIDED AS SEGMENTS (PIGTAILS) (SAMPLE #S (B)(6)) AND THE PATIENT SAMPLE (#(B)(6)) CONSISTED OF RED CELLS IN A TUBE. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR AND PATIENT SAMPLES WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED THE FOLLOWING RESULTS: SAMPLE # (B)(6) SHOWED A +/- REACTION. SAMPLE # (B)(6) SHOWED A POSITIVE REACTION. SAMPLE # (B)(6) SHOWED A NEGATIVE REACTION. BECAUSE ALL SAMPLES DID NOT CONTAIN ANY SERUM OR PLASMA REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WAS NOT POSSIBLE. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR THE MOLECULAR TYPING ONLY ONE SAMPLE, # (B)(6), WAS SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. THE RESULT IS: ABO* B101 / B101. THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE SAMPLE WAS CONFIRMED BY TESTING THE NE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6111924 ↗
• MalfunctionNov 18, 2016False Positive Result; Defective Component

  THE CUSTOMER REPORTED THAT TWO DONOR SAMPLES AND ONE PATIENT SAMPLE WERE TYPED AS BLOOD GROUP B, BUT SHOWED WEAK POSITIVE REACTIONS WITH SERACLONE ANTI-A. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE SAMPLES THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE TWO DONOR SAMPLES WERE PROVIDED AS SEGMENTS (PIGTAILS) (SAMPLE #(B)(6)) AND THE PATIENT SAMPLE (B)(6)) CONSISTED OF RED CELLS IN A TUBE. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR AND PATIENT SAMPLES WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED THE FOLLOWING RESULTS: SAMPLE #(B)(6) SHOWED A +/- REACTION. SAMPLE #(B)(6) SHOWED A POSITIVE REACTION. SAMPLE #(B)(6) SHOWED A NEGATIVE REACTION. BECAUSE ALL SAMPLES DID NOT CONTAIN ANY SERUM OR PLASMA REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WAS NOT POSSIBLE. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR THE MOLECULAR TYPING ONLY ONE SAMPLE, #(B)(6), WAS SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. THE RESULT IS: (B)(6). THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE SAMPLE WAS CONFIRMED BY TESTING THE NEGATIVE AND POSITIV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6111921 ↗
• MalfunctionNov 18, 2016False Positive Result; Defective Device

  THE CUSTOMER REPORTED THAT TWO DONOR SAMPLES AND ONE PATIENT SAMPLE WERE TYPED AS BLOOD GROUP B, BUT SHOWED WEAK POSITIVE REACTIONS WITH SERACLONE ANTI-A. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE SAMPLES THAT HAD CAUSED FALSE POSITIVE REACTIONS. THE TWO DONOR SAMPLES WERE PROVIDED AS SEGMENTS (PIGTAILS) ((B)(6)) AND THE PATIENT SAMPLE (B)(6)) CONSISTED OF RED CELLS IN A TUBE. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR AND PATIENT SAMPLES WITH THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE METHOD IMMEDIATE SPIN ACCORDING THE INSTRUCTION FOR USE AND YIELDED THE FOLLOWING RESULTS: (B)(6). BECAUSE ALL SAMPLES DID NOT CONTAIN ANY SERUM OR PLASMA REVERSE TYPING AND TESTING FOR IRREGULAR RED CELL ANTIBODIES WAS NOT POSSIBLE. DUE TO THE FACT THAT SEGMENTS (PIGTAILS) ARE NOT SUITED FOR THE MOLECULAR TYPING ONLY ONE SAMPLE, (B)(6), WAS SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR ABO TYPING. THE RESULT IS: ABO* B101 / B101. THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE SAMPLE WAS CONFIRMED BY TESTING THE NEGATIVE AND POSITIVE SPECIFICITY AS WELL AS POTENCY. THE INSTRUCTION FOR USE OF SERACLONE ANTI-A CONTAINS IN THE CHAPTER "SPECIFIC PER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6111919 ↗
• MalfunctionOct 17, 2014False Positive Result; False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 4179791 ↗
• MalfunctionOct 17, 2014False Positive Result; False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 4179786 ↗