Seraclone® Anti-D (RH1) Blend 802033100Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07611969950201), received between Oct 5, 2016 and Oct 23, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “False Negative 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A PATIENT SAMPLE THAT WAS TYPED AS RHD NEGATIVE USING THE IMMEDIATE SPIN TEST. HOWEVER, A REFERENCE LAB TYPED THE SAME PATIENT AS RHD POSITIVE USING GEL CARDS ON AUTOMATED INSTRUMENT (ORTHO VISION). THE CUSTOMER WAS NOT AWARE THAT ACCORDING TO THE IFU A WEAK D TEST HAD TO BE PERFORMED IN ORDER TO IDENTIFY A WEAK/VARIANT D ANTIGEN. THE PATIENT SAMPLE WAS RETESTED AND THE CUSTOMER OBTAINED A POSITIVE REACTION IN THE AHG PHASE. THE CUSTOMER ANNOUNCED TO SEND IN THE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. AS OF TODAY, WE HAVE NOT YET RECEIVED THE PATIENT MATERIAL IN ORDER TO CONFIRM THE ASSUMPTION ABOUT THE PRESENCE OF A WEAK/VARIANT D ANTIGEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513218 ↗
• MalfunctionApr 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT RESULTS AFTER PERFORMING IMMEDIATE SPIN, USING THE SERACLONE ANTI-D (RH1) BLEND. THE CUSTOMER STATED THAT THE PATIENT RESULTS WERE NEGATIVE BUT WHEN THE REACTIONS REMAINED IN THE TUBE, THE REACTION CHANGED TO POSITIVE. THE CUSTOMER RETURNED TWO VIALS OF THE PRODUCT SAMPLE SERACLONE ANTI-D (RH1) BLEND FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED BOTH SAMPLES FOR POTENCY IN PARALLEL WITH THEIR RETENTION SAMPLE AND A REFERENCE LOT. ALL FOUR REAGENT SAMPLES SHOWED COMPARABLE RESULTS AND MET THE MINIMUM TITER. IN ADDITION, BOTH VIALS OF THE COMPLAINT SAMPLE WERE TESTED WITH DIFFERENT SAMPLES FOR THE SPECIFICITY OF THE METHODS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU), INCLUDING THE IMMEDIATE SPIN METHOD. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS UNJUSTIFIED. COMPLAINT SAMPLE AND RETENTION SAMPLE REACTED AS EXPECTED. ALL ACCEPTANCE CRITERIA REGARDING SPECIFICITY AND POTENCY WERE MET. NEVERTHELESS WE REFERRED THE CUSTOME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018390 ↗
• MalfunctionNov 16, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF PATIENT SAMPLES WITH SERACLONE ANTI-D BLEND IN THE TUBE METHOD IMMEDIATE SPIN. THE CUSTOMER STATED THAT THE POSITIVE REACTIONS WITH SERACLONE ANTI-D (RH1) BLEND ARE WEAKER THAN THE REACTIONS ON THE IMMUCOR ECHO INSTRUMENT. THE CUSTOMER RETURNED A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO ONE PATIENT SAMPLE. WHILE OUR QUALITY CONTROL LABORATORY WAS WAITING FOR THE MATERIAL TO ARRIVE, THEY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR POTENCY IN PARALLEL WITH A REFERENCE LOT. BOTH REAGENT SAMPLES SHOWED COMPARABLE RESULTS AND MET THE MINIMUM TITER. FURTHERMORE, THE RETENTION SAMPLE AND THE REFERENCE WERE TESTED WITH DIFFERENT SAMPLES FOR SPECIFICITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WHEN OUR QUALITY CONTROL LABORATORY RECEIVED THE CUSTOMER'S MATERIAL, THEY TESTED THE COMPLAINT SAMPLE FOR POTENCY IN PARALLEL WITH THE RETENTION SAMPLE AND A REFERENCE LOT. ALL THREE REAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147372 ↗
• MalfunctionNov 9, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF PATIENT SAMPLES WITH SERACLONE ANTI-D BLEND IN THE TUBE METHOD IMMEDIATE SPIN. THE CUSTOMER RETURNED THE THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESING AND ALSO FOUR PATIENT SAMPLES. OU QUALITY CONTROL LABORATORY TESTED THE PRODUCT SAMPLE RETURNED BY THE CUSTOMER FOR POTENCY IN PARALLEL WITH THEIR RETENTION SAMPLE AND A REFERENCE LOT. ALL THREE REAGENT SAMPLES SHOWED COMPARABLE RESULTS AND MET THE MINIMUM TITER. FURTHERMORE, COMPLAINT SAMPLE, RETENTION SAMPLE AND REFERENCE LOT WERE TESTED WITH DIFFERENT SAMPLES FOR SPECIFICITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE PATIENT SAMPLES THE CUSTOMER SENT IN WERE ALSO TESTED WITH THE COMPLAINT SAMPLE, THE RETENTION SAMPLE, AND THE REFERENCE LOT. AGAIN, ALL RESULTS WERE COMPARABLE. THREE OF FOUR PATIENT SAMPLES SHOWED CLEARLY POSITIVE RESULTS IN THE TUBE METHOD IMMEDIATE SPIN, WHILE ONE SAMPLE, NO. (B)(6), SHOWED NEGATIVE RESULTS. BUT ALL FOUR SAMPLES SHOWED STRONGLY PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099496 ↗
• MalfunctionOct 19, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH SERACLONE ANTI-D BLEND. THE CUSTOMER SENT IN THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTIGATIONAL TESTING AND ALSO PATIENT MATERIAL THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE RETURNED BY THE CUSTOMER FOR POTENCY AND SPECIFICITY IN PARALLEL WITH THEIR RETENTION SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT AND ALSO A REFERENCE LOT. THE COMPLAINT SAMPLE MET THE MINIMUM TITER OF 32. ALL THREE REAGENTS (COMPLAINT SAMPLE, RETENTION SAMPLE AND REFERENCE LOT) SHOWED COMPARABLE RESULTS. ALL ACCEPTANCE CRITERIA WERE MET. BOTH SPECIMENS PROVIDED BY CUSTOMER WERE TESTED IN THE IMMEDIATE SPIN METHOD: SAMPLE #: (B)(6) SHOWED A +/- REACTION, WHILE SPECIMEN #T1800346 SHOWED A 2+ POSITIVE REACTION. IN ADDITION BOTH SPECIMENS WERE TESTED IN THE INDIRECT ANTI-GLOBULIN TEST ACCORDING TO THE RECOMMENDATION OF THE IFU AND SHOWED STRONG POSITIVE REACTIONS. BASED ON THE SEROLOGICAL TEST RESULTS A WEAK D RESPECTIVELY D VARIANT WAS SUSPECTED FOR BOTH SPECIMENS. THEREFORE, THEY WERE SENT FOR MOLECULAR RH(D) TYPING TO AN EXTERNAL LABORATORY. BOTH SAMPLES WERE TYPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12655317 ↗
• MalfunctionOct 11, 2021False Negative Result; False Negative Result

  ORIGINALLY THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH SERACLONE ANTI-D BLEND. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING BUT SENT IN THE PATIENT SAMPLE. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IN PARALLEL WITH A REFERENCE LOT FOR POTENCY AND SPECIFICITY. ALL ACCEPTANCE CRITERIA WERE MET. BOTH LOTS SHOWED COMPARABLE RESULTS. ADDITIONALLY OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLES #(B)(6) AND #(B)(6) WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IN THE METHOD IMMEDIATE SPIN AND IN THE INDIRECT ANTIGLOBULIN TEST (IAT, 30 MINUTES AT 37°C) ACCORDING TO THE RECOMMENDATION OF THE IFU. BOTH PATIENT SAMPLES SHOWED A WEAK POSITIVE REACTION IN THE IMMEDIATE SPIN TEST AND A STRONG POSITIVE REACTION IN THE IAT. BASED ON THE SEROLOGICAL TEST RESULTS A WEAK D RESPECTIVELY D VARIANT WAS SUSPECTED FOR BOTH SPECIMENS. THEREFORE, THEY WERE SENT FOR MOLECULAR RH(D) TYPING TO AN EXTERNAL LABORATORY. BOTH SAMPLES WERE TYPED AS (B)(6). THE SUBSEQUENT SEQUENCING OF THE RHCE GENE DID NOT SHOW ANY MUTATION THAT COULD EXPLAIN D-LIKE STRUCTURES THAT MIGHT BE MIMICKE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12604917 ↗
• MalfunctionOct 11, 2021False Negative Result; False Negative Result

  ORIGINALLY THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH SERACLONE ANTI-D BLEND. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING BUT SENT IN THE PATIENT SAMPLE. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IN PARALLEL WITH A REFERENCE LOT FOR POTENCY AND SPECIFICITY. ALL ACCEPTANCE CRITERIA WERE MET. BOTH LOTS SHOWED COMPARABLE RESULTS. ADDITIONALLY OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLES (B)(6) AND (B)(6)WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IN THE METHOD IMMEDIATE SPIN AND IN THE INDIRECT ANTIGLOBULIN TEST (IAT, 30 MINUTES AT 37°C) ACCORDING TO THE RECOMMENDATION OF THE IFU. BOTH PATIENT SAMPLES SHOWED A WEAK POSITIVE REACTION IN THE IMMEDIATE SPIN TEST AND A STRONG POSITIVE REACTION IN THE IAT. BASED ON THE SEROLOGICAL TEST RESULTS A WEAK D RESPECTIVELY D VARIANT WAS SUSPECTED FOR BOTH SPECIMENS. THEREFORE, THEY WERE SENT FOR MOLECULAR RH(D) TYPING TO AN EXTERNAL LABORATORY. BOTH SAMPLES WERE TYPED AS CCDDEE. THE SUBSEQUENT SEQUENCING OF THE RHCE GENE DID NOT SHOW ANY MUTATION THAT COULD EXPLAIN D-LIKE STRUCTURES THAT MIGHT BE MIMICKED B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12604916 ↗
• MalfunctionAug 31, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE OF A PREGNANT WOMAN SHOWED A FALSE NEGATIVE REACTION WITH SERACLONE ANTI-D (RH1) BLEND. THE CUSTOMER STATED THAT THE SAMPLE SHOWED A 4+ POSITIVE REACTION WITH ANTI-D OF ABO/RH GEL CARD ON ORTHO VISION AUTOMATED METHOD. THE TUBE TESTING WITH SERACLONE ANTI-D (RH1) BLEND WAS NOT TAKEN TO THE INDIRECT ANTIGLOBULIN TEST (IAT). THE CUSTOMER STATED THAT HE VERIFIED THAT ALL INSTRUCTIONS OF THE INSTRUCTION FOR USE (IFU) WERE FOLLOWED. THE TUBE TEST WAS NOT REPEATED. THE CUSTOMER SENT THE PATIENT SAMPLE FOR MOLECULAR RHD GENOTYPING. THE OUTCOME OF THE INVESTIGATION WAS RH(D) NORMAL, NOT A VARIANT OR WEAK D. THE CUSTOMER DID NEITHER PROVIDE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED THE FALSE NEGATIVE TEST RESULT. THEREFORE, OUR QUALITY CONTROL LABORATORY MANUALLY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR POTENCY AND SPECIFICITY. THE TESTING WAS DONE IN PARALLEL WITH A REFERENCE LOT. THE ACCEPTANCE CRITERION FOR THE MINIMUM TITER 32 WAS MET. ACCORDING TO THE IFU DIFFERENT RED BLOOD CELL SAMPLES WERE MANUALLY TESTED IN THE IMMEDIATE SPIN AND THE IAT (30 MIN 37°C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12390621 ↗
• MalfunctionJun 2, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A WEAK FALSE POSITIVE REACTION OF A CAP SURVEY SAMPLE WITH SERACLONE ANTI-D BLEND WHEN USED MANUALLY. THE REAGENT OF A COMPETITOR GAVE A NEGATIVE TEST RESULT. THE CUSTOMER SENT IN THE COMPLAINT SAMPLE SERACLONE ANTI-D BLEND FOR INVESTIGATIONAL TESTING, THE CAP SURVEY SAMPLE J-05R THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS AND THE ANTI-D REAGENT OF THE COMPETITOR (QUOTIENT ALBACLONE ANTI-D BLEND, (B)(6)). OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE IN PARALLEL WITH THEIR RETENTION SAMPLE AND A REFERENCE LOT FOR POTENCY. ALL THREE REAGENTS MET THE MINIMUM TITER OF 32 AND SHOWED COMPARABLE RESULTS. THE CAP SURVEY SAMPLE WAS TESTED WITH THE COMPLAINT SAMPLE, THE RETENTION SAMPLE, THE REFERENCE LOT AND QUOTIENT ALBACLONE ANTI-D BLEND. FOR THESE TESTS THE CAP SURVEY SAMPLE WAS USED READY FOR USE AND WASHED. THE USED TEST METHODS WERE IMMEDIATE SPIN AND THE INDIRECT ANTIGLOBULIN TEST (IAT, 30 MIN AT 37°C). THE CAP SURVEY SAMPLE SHOWED NEGATIVE RESULTS IN ALL TESTS. ADDITIONALLY, THE CAP SURVEY SAMPLE WAS TESTED WITH IH-ANTI-D BLEND IN THE IH-CARD AHG ANTI-IGG, IN THE IH-CARD DVI+ AND IN THE IH-CARD DVI-. AGAIN, ALL RESULTS WERE CLEARLY NEGATIVE. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920746 ↗
• MalfunctionJun 2, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A WEAK FALSE POSITIVE REACTION OF A CAP SURVEY SAMPLE WITH SERACLONE ANTI-D BLEND WHEN USED MANUALLY. THE REAGENT OF A COMPETITOR GAVE A NEGATIVE TEST RESULT. THE CUSTOMER SENT IN THE COMPLAINT SAMPLE SERACLONE ANTI-D BLEND FOR INVESTIGATIONAL TESTING, THE CAP SURVEY SAMPLE J-05R THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS AND THE ANTI-D REAGENT OF THE COMPETITOR (QUOTIENT ALBACLONE ANTI-D BLEND, (B)(6)). OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE IN PARALLEL WITH THEIR RETENTION SAMPLE AND A REFERENCE LOT FOR POTENCY. ALL THREE REAGENTS MET THE MINIMUM TITER OF 32 AND SHOWED COMPARABLE RESULTS. THE CAP SURVEY SAMPLE WAS TESTED WITH THE COMPLAINT SAMPLE, THE RETENTION SAMPLE, THE REFERENCE LOT AND QUOTIENT ALBACLONE ANTI-D BLEND. FOR THESE TESTS THE CAP SURVEY SAMPLE WAS USED READY FOR USE AND WASHED. THE USED TEST METHODS WERE IMMEDIATE SPIN AND THE INDIRECT ANTIGLOBULIN TEST (IAT, 30 MIN AT 37°C). THE CAP SURVEY SAMPLE SHOWED NEGATIVE RESULTS IN ALL TESTS. ADDITIONALLY, THE CAP SURVEY SAMPLE WAS TESTED WITH IH-ANTI-D BLEND IN THE IH-CARD AHG ANTI-IGG, IN THE IH-CARD DVI+ AND IN THE IH-CARD DVI-. AGAIN, ALL RESULTS WERE CLEARLY NEGATIVE. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920690 ↗
• MalfunctionJun 2, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A WEAK FALSE POSITIVE REACTION OF A CAP SURVEY SAMPLE WITH SERACLONE ANTI-D BLEND WHEN USED MANUALLY. THE REAGENT OF A COMPETITOR GAVE A NEGATIVE TEST RESULT. THE CUSTOMER SENT IN THE COMPLAINT SAMPLE SERACLONE ANTI-D BLEND FOR INVESTIGATIONAL TESTING, THE CAP SURVEY SAMPLE J-05R THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS AND THE ANTI-D REAGENT OF THE COMPETITOR (QUOTIENT ALBACLONE ANTI-D BLEND, (B)(6)). OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE IN PARALLEL WITH THEIR RETENTION SAMPLE AND A REFERENCE LOT FOR POTENCY. ALL THREE REAGENTS MET THE MINIMUM TITER OF 32 AND SHOWED COMPARABLE RESULTS. THE CAP SURVEY SAMPLE WAS TESTED WITH THE COMPLAINT SAMPLE, THE RETENTION SAMPLE, THE REFERENCE LOT AND QUOTIENT ALBACLONE ANTI-D BLEND. FOR THESE TESTS THE CAP SURVEY SAMPLE WAS USED READY FOR USE AND WASHED. THE USED TEST METHODS WERE IMMEDIATE SPIN AND THE INDIRECT ANTIGLOBULIN TEST (IAT, 30 MIN AT 37°C). THE CAP SURVEY SAMPLE SHOWED NEGATIVE RESULTS IN ALL TESTS. ADDITIONALLY, THE CAP SURVEY SAMPLE WAS TESTED WITH IH-ANTI-D BLEND IN THE IH-CARD AHG ANTI-IGG, IN THE IH-CARD DVI+ AND IN THE IH-CARD DVI-. AGAIN, ALL RESULTS WERE CLEARLY NEGATIVE. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920656 ↗
• MalfunctionMar 15, 2021False Negative Result; Output Problem; False Negative Result; Output Problem

  THE CUSTOMER REPORTED TWO WEAK POSITIVE RESPECTIVELY FALSE NEGATIVE RESULTS OF THREE PATIENT SAMPLES WITH SERACLONE ANTI-D BLEND. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE AND THREE PATIENT SAMPLES FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THE RETURNED PRODUCT SAMPLE FOR POTENCY AND SPECIFICITY IN THE TUBE TECHNIQUE. THE TESTING WAS DONE IN PARALLEL WITH OUR QC LAB'S RETENTION SAMPLE AND A REFERENCE LOT. THE MINIMUM TITER WAS ALWAYS MET AND ALL THREE REAGENTS SHOWED COMPARABLE RESULTS. THE PATIENT SAMPLES WERE TESTED IN THE IMMEDIATE SPIN METHOD AND SHOWED NEGATIVE RESPECTIVELY +/- REACTIONS. THEN THE PATIENT SAMPLES WERE TESTED IN THE INDIRECT ANTIGLOBULIN TEST AND SHOWED STRONG POSITIVE RESULTS. DUE TO THE TEST RESULTS THE PATIENT SAMPLES WERE SENT FOR FURTHER INVESTIGATION TO AN EXTERNAL LABORATORY. THE OUTCOME OF THE EXTERNAL MOLECULAR TYPING OF THE RH FORMULA AND THE SEQUENCING WAS: SAMPLE #(B)(6): CC. EE, RHD WEAK D TYPE 4.0 (RHD 09.03.01). SAMPLE #(B)(6): CCD. EE WEAK D TYPE 3 (RHD 01W.3). SAMPLE #(B)(6): CC. EE, RHD WEAK D TYPE 4.0 (RHD 09.03.01). ADDITIONALLY, BOTH THE COMPLAINT SAMPLE AND THE RETENTION SAMPLE WERE TESTED WITH DIFFERENT DONOR SAMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11482521 ↗
• MalfunctionMar 15, 2021False Negative Result; Output Problem; False Negative Result; Output Problem

  THE CUSTOMER REPORTED TOO WEAK POSITIVE RESPECTIVELY FALSE NEGATIVE RESULTS OF THREE PATIENT SAMPLES WITH SERACLONE ANTI-D BLEND. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE AND THREE PATIENT SAMPLES FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THE RETURNED PRODUCT SAMPLE FOR POTENCY AND SPECIFICITY IN THE TUBE TECHNIQUE. THE TESTING WAS DONE IN PARALLEL WITH OUR QC LAB'S RETENTION SAMPLE AND A REFERENCE LOT. THE MINIMUM TITER WAS ALWAYS MET AND ALL THREE REAGENTS SHOWED COMPARABLE RESULTS. THE PATIENT SAMPLES WERE TESTED IN THE IMMEDIATE SPIN METHOD AND SHOWED NEGATIVE RESPECTIVELY +/- REACTIONS. THEN THE PATIENT SAMPLES WERE TESTED IN THE INDIRECT ANTIGLOBULIN TEST AND SHOWED STRONG POSITIVE RESULTS. DUE TO THE TEST RESULTS THE PATIENT SAMPLES WERE SENT FOR FURTHER INVESTIGATION TO AN EXTERNAL LABORATORY. THE OUTCOME OF THE EXTERNAL MOLECULAR TYPING OF THE RH FORMULA AND THE SEQUENCING WAS: SAMPLE # (B)(6): CC..EE, RHD * WEAK D TYPE 4.0 (RHD * 09.03.01). SAMPLE # (B)(6): CCD.EE WEAK D TYPE 3 (RHD * 01W.3). SAMPLE # (B)(6): CC..EE, RHD *WEAK D TYPE 4.0 (RHD * 09.03.01). ADDITIONALLY, BOTH THE COMPLAINT SAMPLE AND THE RETENTION SAMPLE WERE TESTED WITH DIFFERENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11482479 ↗
• MalfunctionMar 15, 2021False Negative Result; Output Problem; False Negative Result; Output Problem

  THE CUSTOMER REPORTED TOO WEAK POSITIVE RESPECTIVELY FALSE NEGATIVE RESULTS OF THREE PATIENT SAMPLES WITH SERACLONE ANTI-D BLEND. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE AND THREE PATIENT SAMPLES FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THE RETURNED PRODUCT SAMPLE FOR POTENCY AND SPECIFICITY IN THE TUBE TECHNIQUE. THE TESTING WAS DONE IN PARALLEL WITH OUR QC LAB'S RETENTION SAMPLE AND A REFERENCE LOT. THE MINIMUM TITER WAS ALWAYS MET AND ALL THREE REAGENTS SHOWED COMPARABLE RESULTS. THE PATIENT SAMPLES WERE TESTED IN THE IMMEDIATE SPIN METHOD AND SHOWED NEGATIVE RESPECTIVELY +/- REACTIONS. THEN THE PATIENT SAMPLES WERE TESTED IN THE INDIRECT ANTIGLOBULIN TEST AND SHOWED STRONG POSITIVE RESULTS. DUE TO THE TEST RESULTS THE PATIENT SAMPLES WERE SENT FOR FURTHER INVESTIGATION TO AN EXTERNAL LABORATORY. THE OUTCOME OF THE EXTERNAL MOLECULAR TYPING OF THE RH FORMULA AND THE SEQUENCING WAS: SAMPLE # (B)(6): CC.EE, RHD WEAK D TYPE 4.0 (RHD 09.03.01). SAMPLE # (B)(6): CCD.EE WEAK D TYPE 3 (RHD 01W.3). SAMPLE # (B)(6): CC.EE, RHD WEAK D TYPE 4.0 (RHD 09.03.01). ADDITIONALLY, BOTH THE COMPLAINT SAMPLE AND THE RETENTION SAMPLE WERE TESTED WITH DIFFERENT DONOR SAMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11482461 ↗
• MalfunctionJan 9, 2020False Negative Result; Defective Component

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF ONE PATIENT SAMPLE WHEN TESTED WITH SERACLONE ANTI-D BLEND IN THE TUBE METHOD. THE CUSTOMER STATED THAT THE PRE-NATAL PATIENT WAS TYPED AS BLOOD GROUP O RHD NEGATIVE BY TWO TECHNICIANS ON (B)(6) 2019. THIS RESULT WAS CONFIRMED BY A QUICK STICK TEST. ON (B)(6) 2019 THE SAME PATIENT RETURNED TO HAVE HER ABO/RH TYPING PERFORMED USING THE TUBE METHOD. THIS TIME THE RESULT WAS RHD POSITIVE. FOR THIS TESTING THE CUSTOMER USED SERACLONE ANTI-D BLEND LOT 8905130-04. DUE TO THE DISCREPANT TEST RESULTS THE CUSTOMER THOUGHT THE PATIENT MIGHT HAVE A VARIANT AND WOULD LIKE FURTHER TESTS PERFORMED. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT SERACLONE ANTI-D BLEND FOR INVESTIGATIONAL TESTING, BUT ONE PATIENT SAMPLE. THE 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 9567560 ↗
• MalfunctionOct 23, 2019False Negative Result; Defective Component

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF TWO RH(D) POSITIVE SAMPLE WITH SERACLONE ANTI-D BLEND IN THE IMMEDIATE SPIN METHOD. THE CUSTOMER STATED THAT THE RESULT OF ONE RH(D) POSITIVE SAMPLE WAS CORRECTLY POSITIVE AFTER USING TWO DROPS OF SERACLONE ANTI-D BLEND LOT 8832110-02. AND THE CUSTOMER RECEIVED A CORRECTLY POSITIVE RESULT OF THE SECOND RH(D) POSITIVE SAMPLE AFTER 15 MINUTES INCUBATION USING SERACLONE ANTI-D BLEND LOT 8905130-04. THE CUSTOMER SITE USUALLY DOES NOT PERFORM THE WEAK D TEST USING THIS REAGENT UNLESS THE SAMPLE IS FROM A NEWBORN. THE CUSTOMER PROVIDED COMPLAINT SAMPLES OF BOTH SERACLONE ANTI-D LOTS (REF #802033100, LOT #8832110-02 AND LOT # 8905130-04) THEY USED AT THE SITE AND TWO SPECIMENS OF ONE PATIENT (BOTH LABELED AS (B)(6) 2019 0500) THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLES AS WELL AS THEIR RETENTION SAMPLES AND A REFERENCE LOT (LOT #8922070-04) FOR POTENCY AND SPECIFICITY. ALL REACTIONS WERE CORRECT. THE MINIMUM TITER OF 32 WAS ALWAYS MET. AND ALL THREE REAGENTS (COMPLAINT SAMPLE AND RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCTS AS WELL AS THE RETENTION SAMPLE OF THE REFERENCE

  Patient problems: Reaction

  MAUDE report 9222723 ↗
• MalfunctionSep 18, 2019False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF TWO RH(D) POSITIVE KNOWN SAMPLES WITH THE USE OF SERACLONE ANTI-D BLEND (LOT #8832110-02) IN THE IMMEDIATE SPIN TUBE TEST. THE CUSTOMER REPEATED THE TEST OF ONE OF THE RH(D) KNOWN POSITIVE SAMPLE ON THE SAME DAY AND RECEIVED A POSITIVE REACTION OF THIS SAMPLE WHEN USING TWO DROPS OF SERACLONE ANTI-D BLEND LOT 8832110-02. ON AUGUST 22, THE TESTING OF THE SECOND RH(D) POSITIVE KNOWN PATIENT WITH THE USE OF SERACLONE ANTI-D BLEND LOT # 8905130-04 IN THE IMMEDIATE SPIN METHOD YIELDED INTO CORRECTLY POSITIVE RESULTS AFTER A 15 MINUTES INCUBATION OF SERACLONE ANTI-D BLEND. THE CUSTOMER DID RETURN THE SUPPOSEDLY DEFECTIVE PRODUCTS AND TWO PATIENT SPECIMENS FOR INVESTIGATIONAL TESTING. THE TESTING 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 LOTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9081017 ↗
• MalfunctionSep 2, 2019Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT D TYPING RESULTS COMPARED TO OTHER REAGENTS (ORTHO, IMMUCOR). TESTING OF A PATIENT SAMPLE WITH SERACLONE ANTI-D (RH1) BLEND GAVE +/- RESULT AT IMMEDIATE SPIN, 1+ AFTER INCUBATING 10 MINUTES AT 37 DEGREES, AND WHEN TESTED AT AHG IT GABE 4+ RESULTS. THE SAME SAMPLE GAVE A 3+ RESULT WHEN TESTED IN IMMEDIATE SPIN USING ORTHO ANTI-D BUT YIELDED AN 1+ REACTION IN THE IMMEDIATE SPIN USING IMMUCOR ANTI-D. THE CUSTOMER ANNOUNCED TO SEND THE SUPPOSEDLY DEFECTIVE PRODUCT THAT HAD CAUSED DISCREPANT RESPECTIVELY WEAKENED RESULTS FOR INVESTIGATIONAL TESTING. WE ARE STILL WAITING FOR THIS SAMPLE. 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 8953426 ↗
• MalfunctionJan 31, 2019False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A DONOR SAMPLE WHEN TESTED WITH SERACLONE ANTI-D BLEND. THE CUSTOMER STATED THAT HE TYPED THE DONOR SAMPLE AS BLOOD GROUP O RH(D) NEGATIVE BUT IT WAS SUPPOSED TO BE BLOOD GROUP O RH(D) POSITIVE. THE EXACT DATE OF EVENT IS UNKNOWN BUT THE CUSTOMER BELIEVES IT TO HAVE HAPPENED AT THE BEGINNING OF (B)(6) 2018. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE DONOR SAMPLE THAT HAD CAUSED A SUPPOSEDLY FALSE NEGATIVE RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF SERACLONE ANTI-D BLEND FOR POTENCY AND SPECIFICITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE MINIMUM TITER WAS MET. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-D BLEND 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 8291666 ↗
• MalfunctionOct 5, 2016False Negative Result; Defective Device

  THE CUSTOMER REPORTED A (B)(6) REACTION OF A PATIENT SAMPLE WHEN TESTED WITH (B)(6). WHEN TESTED A SECOND TIME, THE SAME PATIENT SAMPLE SHOWED A WEAK POSITIVE TEST RESULT. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT AND ALSO THE PATIENT THAT HAD CAUSED THE (B)(6) TEST RESULT. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5998985 ↗