IH-Card AHG Anti-IgG 813422100Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07611969964857), received between Nov 28, 2018 and Oct 29, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (11 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.

• MalfunctionOct 29, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCREPANT DIRECT ANTIGLOBULIN TEST (DAT) RESULTS FOR FIVE NEONATAL SAMPLES TESTED BETWEEN SEPTEMBER 27, 2025, AND OCTOBER 20, 2025. THE BIRTHING HOSPITALS REPORTED POSITIVE DAT IGG RESULTS USING CORD BLOOD SAMPLES, WHILE SUBSEQUENT TESTING AT THE CUSTOMER FACILITY USING EDTA SAMPLES FROM THE SAME NEONATES YIELDED NEGATIVE RESULTS WITH BIO-RAD IH-CARD AHG ANTI-IGG (MANUAL GEL METHOD) AND TUBE TESTING. ALL AFFECTED NEONATES SUBSEQUENTLY DEVELOPED CLINICAL SIGNS OF HEMOLYTIC DISEASE OF THE NEWBORN (HDN) AND TESTED POSITIVE FOR MATERNAL ANTIBODIES. THE DISCREPANCY WAS FIRST BROUGHT TO THE CUSTOMER'S ATTENTION ON (B)(6) 2025, THOUGH ISSUES HAD BEEN OBSERVED AS EARLY AS ON (B)(6) 2025. THE FIRST FOUR SAMPLES (NEONATES 1-4): BLOOD TYPES: ALL BABIES B POSITIVE, ALL MOTHERS O POSITIVE. CLINICAL PRESENTATION: ALL FOUR NEONATES TESTED POSITIVE FOR ANTI-B ANTIBODIES AND SHOWED CLINICAL SIGNS OF HDN. NO SAMPLES WERE AVAILABLE FOR INTERNAL TESTING (BABIES DISCHARGED). FIFTH SAMPLE (NEONATE 5; COLLECTION DATE: ON (B)(6) 2025. BLOOD TYPES: BABY A POSITIVE, MOTHER O POSITIVE. CLINICAL PRESENTATION: REPORTED BY CUSTOMER ON (B)(6) 2025. SAMPLE AVAILABILITY: SAMPLE RETRIEVED AND

  Patient problems: Hemolysis

  MAUDE report 23411603 ↗
• MalfunctionSep 23, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCREPANCIES WHEN COMPARING THE BIO-RAD MANUAL GEL METHOD WITH IMMUCOR'S SOLID SCREEN METHOD ON ECHO INSTRUMENT. THEY OBSERVED FALSE NEGATIVE RESULTS WITH IGG-COATED RED BLOOD CELLS AND MISSED ANTIBODIES ANTI-CW, ANTI-C AND ANTI-E. THE CUSTOMER PROVIDED US WITH EIGHT (8) CARDS FROM THE ALLEGEDLY DEFECTIVE LOT OF IH-CARD AHG ANTI-IGG (RABBIT) AND TWO (2) PATIENT SAMPLES (B)(6). SAMPLE (B)(6) WAS LEAKED OUT UPON ARRIVAL ON OUR PREMISES, AND FOR SAMPLE (B)(6) ONLY A SMALL VOLUME WAS LEFT IN THE ALIQUOT. AT FIRST THE CUSTOMER CARDS AND THE CORRESPONDING COMPLAINT RETENTION SAMPLE OF IH-CARD AHG ANTI-IGG (RABBIT) WERE TESTED MANUALLY IN OUR QUALITY CONTROL LABORATORY WITH FOUR DIFFERENT KNOWN ANTIBODIES (ANTI-C, ANTI-E, ANTI-D AND ANTI-CW) AND ONE ANTIBODY-NEGATIVE DONOR SAMPLE USING IH-PANEL 11 LOT: 9434011. ALL TEST RESULTS WERE AS EXPECTED AND SPECIFIC, THE ANTIBODIES REACTED ACCORDINGLY WITH THE ANTIGEN-POSITIVE CELLS. THE REACTIONS OF THE RETENTION AND CUSTOMER CARDS WERE COMPARABLE. THE CUSTOMER ALSO PROVIDED TWO (2) PATIENT SAMPLES, WHICH REACTED POSITIVE IN THE ANTIBODY IDENTIFICATION TEST, ONLY ON THE ECHO. SAMPLE 110804516 (ANTI-CW) WAS LEAKED OUT UPON A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278405 ↗
• MalfunctionSep 23, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCREPANCIES WHEN COMPARING THE BIO-RAD MANUAL GEL METHOD WITH IMMUCOR'S SOLID SCREEN METHOD ON ECHO INSTRUMENT. THEY OBSERVED FALSE NEGATIVE RESULTS WITH IGG-COATED RED BLOOD CELLS AND MISSED ANTIBODIES ANTI-CW, ANTI-C AND ANTI-E. THE CUSTOMER PROVIDED US WITH EIGHT (8) CARDS FROM THE ALLEGEDLY DEFECTIVE LOT OF IH-CARD AHG ANTI-IGG (RABBIT) AND TWO (2) PATIENT SAMPLES (11095522 AND 110804516). SAMPLE 110804516 WAS LEAKED OUT UPON ARRIVAL ON OUR PREMISES, AND FOR SAMPLE 11095522 ONLY A SMALL VOLUME WAS LEFT IN THE ALIQUOT AT FIRST THE CUSTOMER CARDS AND THE CORRESPONDING COMPLAINT RETENTION SAMPLE OF IH-CARD AHG ANTI-IGG (RABBIT) WERE TESTED MANUALLY IN OUR QUALITY CONTROL LABORATORY WITH FOUR DIFFERENT KNOWN ANTIBODIES (ANTI-C, ANTI-E, ANTI-D AND ANTI-CW) AND ONE ANTIBODY-NEGATIVE DONOR SAMPLE USING IH-PANEL 11 LOT: 9434011. ALL TEST RESULTS WERE AS EXPECTED AND SPECIFIC, THE ANTIBODIES REACTED ACCORDINGLY WITH THE ANTIGEN-POSITIVE CELLS. THE REACTIONS OF THE RETENTION AND CUSTOMER CARDS WERE COMPARABLE. THE CUSTOMER ALSO PROVIDED TWO (2) PATIENT SAMPLES, WHICH REACTED POSITIVE IN THE ANTIBODY IDENTIFICATION TEST, ONLY ON THE ECHO. SAMPLE 110804516 (ANTI-CW)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278371 ↗
• MalfunctionJun 20, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A CORD BLOOD SAMPLE IN THE DAT (DIRECT ANTIGLOBULIN TEST) WITH THE IH-CARD AHG ANTI-IGG ON THE IH-1000. THE CUSTOMER PROVIDED THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG (REF #813422100, LOT #9133030, EXP. 2022-12-18) FOR INVESTGATIONAL TESTING AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. THE CUSTOMER RETURNED THREE SINGLE CARDS OF THE SUPPOSEDLY DEFECTIVE LOT. ADDITIONALLY, THE CUSTOMER RETURNED THE MATERNAL SAMPLE. THE INVESTIGATION 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. WE ARE ALSO WAITING FOR THE TRACE FILES OF THE AFFECTED IH-1000 TO INVESTIGATE THEM AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741567 ↗
• MalfunctionApr 26, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE DAT (DIRECT ANTI-GLOBULIN TEST) RESULTS OF A CORD BLOOD SAMPLE AND AN ADULT SAMPLE WITH IH-CARD AHG ANTI-IGG, PRODUCT # 813422100, LOT # 74020.9126030. THE CUSTOMER TESTED ON THE IH-1000 INSTRUMENT AND MANUALLY AND RECEIVED DISCREPANT RESULTS: THE RESULT OF THE DAT ON THE IH-1000 WAS NEGATIVE. THE CUSTOMER CONFIRMED IT WAS VISUALLY NEGATIVE. THE DAT WAS REPEATED ON THE IH-1000 WITH THE SAME LOT OF IH-CARD AHG ANTI-IGG AND IT WAS CONFIRMED TO BE NEGATIVE. THE CUSTOMER REPEATED THE DAT ON THE IH-1000 WITH THE A DIFFERENT LOT, LOT # 74020.9133030, EXP DATE 12/18/22 AND THE RESULT WAS STILL NEGATIVE. THE CUSTOMER PERFORMED THE DAT IN TUBE BECAUSE THE CORD BLOOD WAS GROUP A AND THE MOTHER WAS GROUP O. WHEN THE DAT WAS PERFORMED BY TUBE TEST THE RESULT WAS 1+ POSITIVE. THIS WAS CONFIRMED BY PERFORMING THE ELUTION. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG FOR INVESTIGATIONAL TESTING BUT TWO PATIENT SAMPLES (CORD BLOOD). THE INVESTIGATION OF OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A CHECK OF THE AFFECTED INSTRUMENT IH-1000 IS ALSO STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14206651 ↗
• MalfunctionApr 26, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE DAT (DIRECT ANTI-GLOBULIN TEST) RESULTS OF A CORD BLOOD SAMPLE AND AN ADULT SAMPLE WITH IH-CARD AHG ANTI-IGG, PRODUCT # 813422100, LOT # 74020.9126030. THE CUSTOMER TESTED ON THE IH-1000 INSTRUMENT AND MANUALLY AND RECEIVED DISCREPANT RESULTS: THE RESULT OF THE DAT ON THE IH-1000 WAS NEGATIVE. THE CUSTOMER CONFIRMED IT WAS VISUALLY NEGATIVE. THE DAT WAS REPEATED ON THE IH-1000 WITH THE SAME LOT OF IH-CARD AHG ANTI-IGG AND IT WAS CONFIRMED TO BE NEGATIVE. THE CUSTOMER REPEATED THE DAT ON THE IH-1000 WITH THE A DIFFERENT LOT, LOT # 74020.9133030, EXP DATE 12/18/22 AND THE RESULT WAS STILL NEGATIVE. THE CUSTOMER PERFORMED THE DAT IN TUBE BECAUSE THE CORD BLOOD WAS GROUP A AND THE MOTHER WAS GROUP O. WHEN THE DAT WAS PERFORMED BY TUBE TEST THE RESULT WAS 1+ POSITIVE. THIS WAS CONFIRMED BY PERFORMING THE ELUTION. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG FOR INVESTIGATIONAL TESTING BUT TWO PATIENT SAMPLES (CORD BLOOD). THE INVESTIGATION OF OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A CHECK OF THE AFFECTED INSTRUMENT IH-1000 IS ALSO STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14206631 ↗
• MalfunctionApr 26, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE DAT (DIRECT ANTI-GLOBULIN TEST) RESULTS OF A CORD BLOOD SAMPLE AND AN ADULT SAMPLE WITH IH-CARD AHG ANTI-IGG, PRODUCT # 813422100, LOT # 74020.9126030. THE CUSTOMER TESTED ON THE IH-1000 INSTRUMENT AND MANUALLY AND RECEIVED DISCREPANT RESULTS:THE RESULT OF THE DAT ON THE IH-1000 WAS NEGATIVE. THE CUSTOMER CONFIRMED IT WAS VISUALLY NEGATIVE. THE DAT WAS REPEATED ON THE IH-1000 WITH THE SAME LOT OF IH-CARD AHG ANTI-IGG AND IT WAS CONFIRMED TO BE NEGATIVE. THE CUSTOMER REPEATED THE DAT ON THE IH-1000 WITH THE A DIFFERENT LOT, LOT # 74020.9133030, EXP DATE 12/18/2022 AND THE RESULT WAS STILL NEGATIVE. THE CUSTOMER PERFORMED THE DAT IN TUBE BECAUSE THE CORD BLOOD WAS GROUP A AND THE MOTHER WAS GROUP O. WHEN THE DAT WAS PERFORMED BY TUBE TEST THE RESULT WAS 1+ POSITIVE. THIS WAS CONFIRMED BY PERFORMING THE ELUTION. THE CUSTOMER PROVIDED THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG FOR INVESTIGATIONAL TESTING AND ALSO TWO PATIENT SAMPLES. THE INVESTIGATION OF OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A CHECK OF THE AFFECTED INSTRUMENT IH-1000 IS ALSO STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14205946 ↗
• MalfunctionApr 26, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE DAT (DIRECT ANTI-GLOBULIN TEST) RESULTS OF A CORD BLOOD SAMPLE AND AN ADULT SAMPLE WITH IH-CARD AHG ANTI-IGG, PRODUCT # 813422100, LOT # 74020.9126030. THE CUSTOMER TESTED ON THE IH-1000 INSTRUMENT AND MANUALLY AND RECEIVED DISCREPANT RESULTS:THE RESULT OF THE DAT ON THE IH-1000 WAS NEGATIVE. THE CUSTOMER CONFIRMED IT WAS VISUALLY NEGATIVE. THE DAT WAS REPEATED ON THE IH-1000 WITH THE SAME LOT OF IH-CARD AHG ANTI-IGG AND IT WAS CONFIRMED TO BE NEGATIVE. THE CUSTOMER REPEATED THE DAT ON THE IH-1000 WITH THE A DIFFERNT LOT, LOT # 74020.9133030, EXP DATE 12/18/22 AND THE RESULT WAS STILL NEGATIVE. THE CUSTOMER PERFORMED THE DAT IN TUBE BECAUSE THE CORD BLOOD WAS GROUP A AND THE MOTHER WAS GROUP O. WHEN THE DAT WAS PERFORMED BY TUBE TEST THE RESULT WAS 1+ POSITIVE. THIS WAS CONFIRMED BY PERFORMING THE ELUTION. THE CUSTOMER PROVIDED THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG FOR INVESTIGATIONAL TESING AND ALSO TWO PATIENT SAMPLES. THE INVESTIGATION OF OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A CHECK OF THE AFFECTED INSTRUMENT IH-1000 IS ALSO STIL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14205935 ↗
• MalfunctionJun 23, 2020False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE DONOR SAMPLE IN THE CROSSMATCH TEST DURING THE VALIDATION OF HER IH-CENTRIFUGE L. THE CUSTOMER STATED THAT SHE PERFORMED THE CROSSMATCH ON A UNIT WHICH WAS TYPED AS C ANTIGEN POSITIVE WITH A PATIENT PLASMA THAT DEMONSTRATED ANTI-C. THE CROSSMATCH SHOULD HAVE BEEN POSITIVE (INCOMPATIBLE), BUT IT WAS NEGATIVE (COMPATIBLE). THE CUSTOMER REPEATED THE CROSSMATCH AND YIELDED AGAIN A NEGATIVE (COMPATIBLE) RESULT. THE CUSTOMER PERFORMED THE CROSSMATCH TESTS MANUALLY USING IH-INCUBATOR L AND IH-CENTRIFUGE L. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG, TWO DONOR SEGMENTS (LABELED AS (B)(6)) AND AN ALIQUOT LABELED AS ANTI-C. OUR QUALITY CONTROL LABORATORY PERFORMED THE CROSSMATCH WITH THE SAMPLES AND THE IH-CARD PROVIDED BY THE CUSTOMER AND YIELDED A NEGATIVE (COMPATIBLE) RESULT. SO THE TESTING IN OUR QUALITY CONTROL LABORATORY CONFIRMED THE CUSTOMER´S FINDING. ADDITIONALLY OUR QUALITY CONTROL LABORATORY PERFORMED THE CROSSMATCH WITH THE DONOR UNIT AND TWO DIFFERENT ANTI- C SAMPLES. IN BOTH CASES THE CROSSMATCH WAS CORRECTLY POSITIVE. FURTHERMORE CROSSMATCH WAS PERFORMED WITH THE CUSTOMER'S ALIQUOT ANTI-C AND THREE AD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10183856 ↗
• MalfunctionJun 23, 2020False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE DONOR SAMPLE IN THE CROSSMATCH TEST DURING THE VALIDATION OF HER IH-CENTRIFUGE L. THE CUSTOMER STATED THAT SHE PERFORMED THE CROSSMATCH ON A UNIT WHICH WAS TYPED AS C ANTIGEN POSITIVE WITH A PATIENT PLASMA THAT DEMONSTRATED ANTI-C. THE CROSSMATCH SHOULD HAVE BEEN POSITIVE (INCOMPATIBLE), BUT IT WAS NEGATIVE (COMPATIBLE). THE CUSTOMER REPEATED THE CROSSMATCH AND YIELDED AGAIN A NEGATIVE (COMPATIBLE) RESULT. THE CUSTOMER PERFORMED THE CROSSMATCH TESTS MANUALLY USING IH-INCUBATOR L AND IH-CENTRIFUGE L. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG, TWO DONOR SEGMENTS (LABELED AS (B)(6)) AND AN ALIQUOT LABELED AS ANTI-C. OUR QUALITY CONTROL LABORATORY PERFORMED THE CROSSMATCH WITH THE SAMPLES AND THE IH-CARD PROVIDED BY THE CUSTOMER AND YIELDED A NEGATIVE (COMPATIBLE) RESULT. SO THE TESTING IN OUR QUALITY CONTROL LABORATORY CONFIRMED THE CUSTOMER¿S FINDING. ADDITIONALLY OUR QUALITY CONTROL LABORATORY PERFORMED THE CROSSMATCH WITH THE DONOR UNIT AND TWO DIFFERENT ANTI- C SAMPLES. IN BOTH CASES THE CROSSMATCH WAS CORRECTLY POSITIVE. FURTHERMORE CROSSMATCH WAS PERFORMED WITH THE CUSTOMER'S ALIQUOT ANTI-C AND THREE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10183855 ↗
• MalfunctionJun 23, 2020False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE DONOR SAMPLE IN THE CROSSMATCH TEST DURING VALIDATION OF HER IH-CENTRIFUGE L. THE CUSTOMER STATED THAT SHE PERFORMED THE CROSSMATCH ON A UNIT WHICH WAS TYPED AS C ANTIGEN POSITIVE WITH A PATIENT PLASMA THAT DEMONSTRATED ANTI-C. THE CROSSMATCH SHOULD HAVE BEEN POSITIVE (INCOMPATIBLE), BUT IT WAS NEGATIVE (COMPATIBLE). THE CUSTOMER PERFORMED THE CROSSMATCH MANUALLY USING IH-INCUBATOR L AND IH-CENTRIFUGE L. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG, TWO DONOR SEGMENTS (LABELED AS (B)(6)) AND AN ALIQUOT LABELED AS ANTI-C. OUR QUALITY CONTROL LABORATORY PERFORMED THE CROSSMATCH WITH THE SAMPLES AND THE IH-CARD THE CUSTOMER HAD PROVIDED AND YIELDED A NEGATIVE (COMPATIBLE) RESULT. SO THE TESTING OF OUR QUALITY CONTROL LABORATORY CONFIRMED THE CUSTOMER´S FINDING. ADDITIONALLY OUR QUALITY CONTROL LABORATORY PERFORMED THE CROSSMATCH WITH THE DONOR UNIT AND TWO DIFFERENT ANTI- C SAMPLES. IN BOTH CASES THE CROSSMATCH WAS CORRECTLY POSITIVE. FURTHERMORE THE CROSSMATCH WAS PERFORMED WITH THE ALIQUOT ANTI-C OF CUSTOMER AND THREE ADDITIONAL C ANTIGEN POSITIVE RED BLOOD CELLS. ONLY ONE RED BLOOD CELL YIELDED A WEAK POSITIV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10183842 ↗
• MalfunctionNov 28, 2018False Positive Result; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A SPECIMEN WAS TESTED AS A RH(D) POSITIVE ON IH-1000 USING THE IH CARD AHG ANTI-IGG. BUT WHEN THE SPECIMEN WAS RE-TESTED MANUALLY, THE RESULT WAS B RH(D) POSITIVE. THE CUSTOMER REPEATED THE TESTING ON IH-1000 AND THE RESULT CAME BACK AS B RH(D) POSITIVE. THE INFORMATION PROVIDED BY THE CUSTOMER AND THE COMPLAINED IH-CARD DO NOT MATCH. THE CUSTOMER REPORTED AN INCORRECT ABO BLOOD GROUP TYPING, BUT FILED HIS COMPLAINT FOR AN IH-CARD AHG ANTI-IGG WHICH IS NOT SUITED FOR ABO BLOOD GROUP TYPING, BUT FOR ANTIBODY SCREENING AND IDENTIFICATION. THEREFORE OUR QUALITY CONTROL LABORATORY REQUIRED THE CORRECT PRODUCT AND LOT INFORMATION, BUT THE CUSTOMER HAS SO FAR NOT COME FORWARD WITH THIS INFORMATION. DUE TO THE LACK OF INFORMATION A TESTING OF THE RETENTION SAMPLE HAS NOT YET BEEN PERFORMED. AND BECAUSE OF THE MISSING LOT INFORMATION A REVIEW OF THE BATCH RECORD DOCUMENTATION OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS NOT POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8110185 ↗