IH-Card ABO/D(DVI-)+Rev A1,B 813112100Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 07611969964529), received between Oct 23, 2018 and Apr 28, 2026 — classified as 127 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (102 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 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Display or Visual Feedback Problem

  USER REPORTED MULTIPLE CARDS WITHIN THE SAME LOT THAT HAVE A LOW GEL-LEVEL ON THE ANTI-D WELL ONLY. IT SEEMS THAT THE AGGLUTINATION IS LOWER THAN EXPECTED DUE TO THE LOW GEL VOLUME. THUS, IH-COM IS INTERPRETING AS 2+, WHEN THE INTERPRETATION SHOULD BE EITHER 3+ OR 4+.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019743 ↗
• MalfunctionMar 21, 2026False Positive Result

  THE USER INDICATED GETTING A FALSE POSITIVE WITH THE ANTI-D WELL WHEREAS THEY HAD TYPED THE PATIENT AS B RHD NEGATIVE. INVESTIGATION: - DATA REVIEW: THE RHD NEGATIVE RESULT WAS CONFIRMED AFTER SEVERAL REPEATS IN THE SAME WORK CONDITIONS, AND ALSO IN MANUAL WITH TUBE TECHNIQUE. - TREND ANALYSIS : ON THE (B)(6)., 6 COMPLAINTS ON THE IH-CARD ABO/D(DVI-)+REV A1B PN 813112100 PRODUCT REFERENCE. BUT THIS CASE IN THE UNIQUE RECORD ON THE LOT 9546010. - BATCH RECORDS : THE MANUFACTURING QUALITY RECORDS FOR THE REPORTED PRODUCTS ARE ALL IN COMPLIANCE AND THAT ALL SPECIFICATIONS WERE MET AT BATCH RELEASE. - TRACES FILES ANALYSIS : SEVERAL POTENTIAL EXPLANATIONS WERE CONSIDERED, INCLUDING (DRIED GEL IN THE ANTI-DVI- WELL, FIBRIN IN THE RBC DILUTION, CARRYOVER BETWEEN THE WELLS, OR INTER-SAMPLE CARRYOVER FROM THE PRIOR SAMPLE "(B)(6)," WHICH IS OF O BLOOD TYPE AND CONTAINS HIGH TITERS OF ANTI-A AND ANTI-B ANTIBODIES). UNFORTUNATELY, NONE OF THESE HYPOTHESES HAVE PROVEN TO BE DEMONSTRABLE OR VALID, DUE TO THE UNAVAILABILITY OF THE GEL CONTROL IMAGE, AND PRIMARILY BECAUSE THE DISPENSING SEQUENCE WENT FROM THE CTL WELL TO THE ANTI-A WELL, PASSING THROUGH THE ANTI-DVI- AND ANTI-B WELLS. AND WE CAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656606 ↗
• MalfunctionFeb 17, 2026False Negative Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ANTI-B RESULT WITH IH-CARD ABO/D(DVI-)+REV A1,B WHEN TESTING ON THEIR IH-1000 INSTRUMENT. A PATIENT SAMPLE WAS TESTED IN DUPLICATE. THE ANTI-B WAS INITIALLY 1 POSITIVE BUT NEGATIVE WHEN REPEATED USING THE SAME INSTRUMENT AND REAGENTS. THE TRACE FILES OF THE AFFECTED INSTRUMENT WERE COLLECTED FOR INVESTIGATION.THE SNAPSHOTS PROVIDED DIDN'T SHOWS ANY ISSUE CONCERNING THIS SAMPLES. THE USER PERFOMED TESTING WITH THE YELLOW WELL AND NOTICED THE SAME FALSE-POSITIVE RESULTS.THE ISSUE COULD NOT BE REPRODUCED BY THE MANUFACTURER. WE ALSO CHECKED THE IH-LISS RETENTION SAMPLES IN DREIEICH, AND AMONG THE 34 BOXES CURRENTLY IN THE REFERENCE STOCK, NO WELLS WITH ABNORMAL COLORATION WERE OBSERVED. THIS LEADS US TO BELIEVE THAT THIS IS AN ISOLATED CASE, AND WE ARE NOT ABLE TO LINK IT TO MANUFACTURING. RESOLUTION: FOR IH-LISS, IT IS SPECIFICALLY INDICATED NOT TO USE THE PRODUCT IN CASE OF TURBIDITY; THIS ALSO APPLIES WHEN THERE ARE VISIBLE COLOR DIFFERENCES IN THE WELLS. IN THIS CONTEXT, OUR RECOMMENDATION IS TO VISUALLY CHECK THE IH-]LISS BEFORE LOADING IT ONTO THE DEVICES, AND IF ANY TURBIDITY OR DISCOLORATION IS OBSERVED, TESTING WITH THAT RACK SHOULD NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362188 ↗
• MalfunctionFeb 3, 2026False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE ANTI-B ON 2 SAMPLES. TESTING WAS PERFORMED USING IH-1000 WITH IH-CARD ABO/D(DVI-)+REV A1,B LOT 9535010, SAMPLES (B)(6) WERE TESTED IN DUPLICATE. THE FALSE POSITIVE ANTI-B REACTION INTERPRETATIONS APPEAR JUSTIFIED. BOTH SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND ALSO TESTED BY TUBE METHOD. REPEAT TESTING FOR BOTH SAMPLES WAS O POSITIVE. THE SHIPMENT FOR THE ABO CARDS WAS RECEIVED 12/1/2025 AND THERE WERE (B)(4) BOXES. THEY HAVE 9 BOXES REMAINING. THE CUSTOMER REMOVED THE ABO CARDS FROM THE INSTRUMENT AND DID SEE SOME REAGENT SPLASHES, SPECIFICALLY IN THE ANTI-D WELLS. THEY SPUN THEM DOWN AND THEY LOOKED BETTER, SO THEY ARE BACK IN USE. CUSTOMER IS A LONG TIME USER THAT IS AWARE OF IFU INSTRUCTIONS FOR STORAGE AND HANDLING OF CARDS. INVESTIGATION: NO OTHER COMPLAINTS FOR THIS LOT REGISTERED. THE PRODUCTION BATCH RECORDS WERE CHECKED, AND ALL MANUFACTURING/QC RECORDS ARE COMPLIANT, AND THERE ARE NO MANUFACTURING-RELATED QUALITY CONCERNS. THE CARDS OF THE RETENTION SAMPLE WERE VISUALLY CHECKED FOR THE SEALING FOIL, THE PRESENCE OF SUPERNATANT, AND GEL HOMOGENEITY, AND SHOWED NO ABNORMALITIES. SEROLOGICAL TESTS WERE PERFORMED USING KNOWN A+ AND B+

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244754 ↗
• MalfunctionAug 25, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCREPANT RHD RESULTS BETWEEN BIO-RAD AND ORTHO GEL. THE SAME PATIENT WAS TESTED ON (B)(6) 2024 (PLEASE SEE REPORT 9610824-2025-000027) AND THEN AGAIN ON (B)(6) 202 (THIS REPORT), USING TWO DIFFERENT LOTS OF IH-CARD ABO(D(DVI-)+REVA1,B ON TWO DIFFERENT IH-1000 INSTRUMENTS THE RHD WAS NEGATIVE EACH TIME IN (B)(6) 2025 THE CUSTOMER WAS NOTIFIED BY THE PATIENT'S PHYSICIAN THAT THE PATIENT WAS TESTED AT ANOTHER FACILITY USING AN UNKNOWN ORTHO REAGENT AND YIELDED A 2+ REACTION. THE CUSTOMER DID NEITHER PROVIDE A PATIENT SAMPLE NOR A PRODUCT SAMPLE OF THE ALLEGEDLY DEFECTIVE IH-CARD FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES OF BOTH LOTS OF THE ALLEGEDLY DEFECTIVE IH-CARDS. FIRST, ALL CARDS FROM THE RETENTION SAMPLES WERE VISUALLY CHECKED REGARDING THE SEALING FOIL, THE PRESENCE OF SUPERNATANT, THE GEL HOMOGENEITY AND THE ABSENCE OF SPATTER IN THE REACTION CHAMBERS. THE SUPERNATANT WAS REDUCED ON ALL CARDS. THE CARDS WERE THEN TESTED ON THE IH-1000. TWO WEEK RHD POSITIVE SPECIFICITY, FOUR HETEROZYGOUS RHD POSITIVE SPECIFICITY AND ONE RHD NEGATIVE SPECIFICITY OF THE RETENTION SAMPLE WERE TESTED ON THE IH-100

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881977 ↗
• MalfunctionAug 25, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCREPANT RHD RESULTS BETWEEN BIO-RAD AND ORTHO GEL. THE SAME PATIENT WAS TESTED ON (B)(6) 2024 (THIS REPORT) AND THEN AGAIN ON (B)(6) 2025 (PLEASE REFER TO REPORT 9610824-2025-000026), USING TWO DIFFERENT LOTS OF IH-CARD ABO(D(DVI-)+REVA1,B ON TWO DIFFERENT IH-1000 INSTRUMENTS THE RHD WAS NEGATIVE EACH TIME IN (B)(6) 2025 THE CUSTOMER WAS NOTIFIED BY THE PATIENT'S PHYSICIAN THAT THE PATIENT WAS TESTED AT ANOTHER FACILITY USING AN UNKNOWN ORTHO REAGENT AND YIELDED A 2+ REACTION. THE CUSTOMER DID NEITHER PROVIDE A PATIENT SAMPLE NOR A PRODUCT SAMPLE OF THE ALLEGEDLY DEFECTIVE IH-CARD FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES OF BOTH LOTS OF THE ALLEGEDLY DEFECTIVE IH-CARDS. FIRST, ALL CARDS FROM THE RETENTION SAMPLES WERE VISUALLY CHECKED REGARDING THE SEALING FOIL, THE PRESENCE OF SUPERNATANT , THE GEL HOMOGENEITY AND THE ABSENCE OF SPATTER IN THE REACTION CHAMBERS. THE SUPERNATANT WAS REDUCED ON ALL CARDS. THE CARDS WERE THEN TESTED ON THE IH-1000. TWO WEEK RHD POSITIVE SPECIFICITY, FOUR HETEROZYGOUS RHD POSITIVE SPECIFICITY AND ONE RHD NEGATIVE SPECIFICITY OF THE RETENTION SAMPLE WERE TESTED ON THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881972 ↗
• MalfunctionMar 6, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION IN THE ANTI-B WELL FOR ONE PATIENT SAMPLE OF BLOOD TYPE A RHD POSITIVE. TESTING WAS CONDUCTED ON THE CUSTOMERS IH-1000 INSTRUMENT. THE CUSTOMER DID NOT PROVIDE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE POSITIVE TEST RESULT. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE AFFECTED LOT. FIRST, ALL CARDS FROM THE RETENTION SAMPLE WERE VISUALLY CHECKED REGARDING THE SEALING FOIL, THE PRESENCE OF SUPERNATANT AND THE GEL HOMOGENEITY AND SHOWED NO ABNORMALTY. FOR THE SEROLOGICAL TESTING, 5 DONORS (BLOOD GROUP A) WITH NEGATIVE SPECIFICITY IN THE ANTI-B CAVITY, AS WELL AS ONE DONOR (BLOOD GROUP B) WITH POSITIVE SPECIFICITY IN THE ANTI-B WERE TESTED ON THE IH-1000. ADDITIONALLY, TWO SAMPLES OF THE IH_BASIC QC SET THAT THE CUSTOMER HAD USED DURING HIS TESTS WERE ALSO USED FOR THIS TEST. ALL RESULTS WERE CORRECT. NO FALSE POSITIVE REACTIONS IN THE ANTI-B CAVITY OCCURRED, ALL SIX DONOR BLOODS REACTED CORRECTLY. NO MANUFACTURING-RELATED QUALITY ISSUE WITH THE CARDS WERE NOTICED. TRACE FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE ANALYZED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534487 ↗
• MalfunctionJan 9, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF ONE PATIENT SAMPLE WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV. A1, B ON THE IH-1000 DURING FORWARD TYPING AND IN THE DIRECT COOMBS TEST. THE PATIENT IS A POSITIVE. THE PATIENT SAMPLE WAS RE-TESTED ON THE SAME DAY AND ON THE SAME INSTRUMENT, USING THE SAME REAGENTS AND ACCURATE RESULTS CONSISTENT WITH THE PATIENT'S HISTORY WERE OBTAINED. TRACE FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE ANALYZED WITH THE FOLLOWING RESULTS: FOR THE SAMPLE IN QUESTION, THREE TESTS WERE REQUESTED AT THE SAME TIME: BLOOD GROUP TEST (BGR), DIRECT ANTIGLOBULIN TEST (DAT), AND ANTIBODY SCREENING. THE ANTIBODY SCREENING TEST RESULTED NEGATIVE WHILE THE BLOOD GROUP TEST AND THE DAT TEST SHOWED UNEXPECTED POSITIVE REACTIONS. THE BGR FORWARD TEST WAS DISPENSED FROM THE CONTROL WELL TO THE ANTI-A WELL, THE DAT WELL 1 WAS SUBSEQUENTLY DISPENSED USING THE SAME DILUTION. ALTHOUGH THE GEL CONTROL WAS NOT ACTIVATED, WE CANNOT SUSPECT INTER-WELL CARRY-OVER CAUSED BY THE PRESENCE OF SUPERNATANT DROPLETS IN THE IH-CARD REACTION CHAMBERS AS SUCH A HYPOTHESIS WOULDN'T EXPLAIN WHY THE CONTROL WELL SHOWED A POSITIVE REACTION SINCE IT WAS FIRST DISPENSED IN THE SEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21109726 ↗
• MalfunctionAug 13, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS ON THE ANTI-B WELL OF 0 IH-CARD ABO/D(DVI-)+REV A1,B WHEN USED ON THE IH-1000. THE SAMPLE WAS FALSE POSITIVE 1+ ON ANTI-B WITH IH-CARD ABO/D(DVI-)+REV A1,B WHILE A REPEAT TESTING FOUR DAYS LATER ON THE SAME INSTRUMENT YIELDED AS NEGATIVE ON ANTI-B. THE CUSTOMER ANNOUNCED TO SEND IN THE PATIENT SAMPLES FOR INVESTIGATIONAL TESTING. WHILE OUR QUALITY CONTROL LAB WAITED FOR THESE SAMPLES, THE STAFF TESTED THEIR RETENTION SAMPLES OF THE SUPPOSEDLY DEFECTIVE IH-CARD ABO/D(DVI-)+REV A1,B. THE LAB TESTED ALSO LOT 9346030 WHICH THE CUSTOMER HAD ALSO USED BUT WHICH HAD NOT RESULTED IN A FALSE POSITIVE RESULT. THE CARDS WERE VISUALLY INSPECTED AND SHOWED NO ABNORMALITIES. THERE WAS SUFFICIENT GEL IN ALL WELLS. INHOMOGENEITY OF THE GEL COLUMNS, AS WELL AS GEL SPLASHES IN THE REACTION CHAMBERS WERE NOT DETECTED. THE SEALING OF THE CARDS WERE FLAWLESS. IN ADDITION, 3 CARDS WERE OPENED FROM EACH BATCH OF CARDS. THERE WASN`T ANY ANTISERUM ON THE BOTTOM OF THE FOIL. TO CHECK THE SPECIFICITY OF THE COMPLAINED CARD BATCH ON THE IH-1000, 14 DIFFERENT EDTA DONOR BLOOD ( 6 X A RHD POS, 5 X O RHD POS, 1 X O RHD NEG, 1 X B RHD POS, 1 X B RHD NEG ) WITH KNOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971683 ↗
• MalfunctionJul 16, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT RESULTS IN THE BACK TYPE OF ONE PATIENT SAMPLE WITH THE BLOOD GROUP O RHD POSITIVE WHEN USING IH-CARD ABO/D(DVI-)+REV A1,B. THE SAMPLE WAS TESTED ON FOUR DIFFERENT INSTRUMENTS, TWO IH-1000 AND TWO IH-500. ONE IH-1000 AND ONE IH-500 SHOWED THE CORRECT REVERSE TYPE, THE OTHER INSTRUMENTS NOT. THE CUSTOMER HAS NOT YET PROVIDED ANY DAILY JOURNALS, THEREFORE IT IS NOT CLEAR WHAT THE DISCREPANCY EXACTLY IS. THE CUSTOMER PROVIDED 12 CARDS OF IH-CARD ABO/D(DVI-)+REV A1,B, IH-CELL A1&B AND PATIENT MATERIAL OF SAMPLE NO (B)(6) FOR INVESTIGATIONAL TESTING. THE PROVIDED MATERIAL OF IH-CELL A1&B HAD ALREADY BEEN EXPIRED WHEN THE COMPLAINT WAS FILED, THEREFORE LOT 9422011 WAS USED FOR INVESTIGATIONAL TESTING. AT FIRST, OUR QUALITY CONTROL LABORATORY INVESTIGATED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IH-CARD ABD/D(DVI-)+REV A1,B. THE VISUAL INSPECTION FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER WAS PASSED WITHOUT ANY IRREGULARITIES. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. IN THE 12 CARDS IH-CARD ABO/D(DVI-)+REV A1,B PROVIDED BY THE CUSTOMER, WE IDENTIFIED GEL/ANTISERUM SPLASHES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19748867 ↗
• MalfunctionJul 4, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF TWO PATIENT SAMPLES WITH THE ANTI-B WELL OF IH-CARD ABO/D(DVI-)+REV. A1, B, LOT: 9336010 ON THEIR IH-1000 INSTRUMENT. A 2+ RESPECTIVELY 3+ REACTION WAS OBTAINED IN THE ANTI-B WELL, BUT REVERSE TYPE INDICATED BLOOD GROUP A. AFTER REPETITION ON THE SAME INSTRUMENT THE CORRECT BLOOD TYPE (BLOOD GROUP A) WAS OBTAINED. THE CUSTOMER PROVIDED US FOUR (4) PATIENT SAMPLES, IH-CELL A1&B LOT 9418011, AND 12 CARDS OF IH-CARD ABD/D(DVI-)+REV A1,B, LOT 9336010 FOR INVESTIGATIONAL TESTING. AT FIRST OUR QUALITY CONTROL LABORATORY CHECKED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IH-CARD ABD/D(DVI-)+REV A1,B. THE VISUAL INSPECTION FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER WAS PASSED WITHOUT ANY IRREGULARITIES. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. THEN QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES AND WITH THE PATIENT SAMPLES PROVIDED BY THE CUSTOMER ON THE IH-1000. AS THE REASON FOR THE COMPLAINT WERE FALSE POSITIVE REACTIONS IN THE ANTI-B, THE FOCUS WAS ON THE TESTING OF BLOOD GROUP A AND O RHD-POSITIVE BLOOD SAMPLES. ALL PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674777 ↗
• MalfunctionJul 2, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF ONE PATIENT SAMPLE WITH THE ANTI-B AND CONTROL WELL OF IH-CARD ABO/D(DVI-)+REV. A1, B, LOT: 9336010 ON THEIR IH-1000 INSTRUMENT. A 2+ RESPECTIVELY 3+ REACTION WAS OBTAINED IN THE ANTI-B AND CONTROL WELL FOR A KNOWN BLOOD GROUP A PATIENT. THE REVERSE TYPE INDICATED THE BLOOD GROUP A. AFTER REPETITION ON THE SAME INSTRUMENT THE CORRECT BLOOD TYPE (BLOOD GROUP A) WAS OBTAINED. THE CUSTOMER PROVIDED US FIVE (5) PATIENT SAMPLES, IH-CELL A1&B LOT 9418011, AND 12 CARDS OF IH-CARD ABD/D(DVI-)+REV A1,B, LOT 9336010 FOR INVESTIGATIONAL TESTING. AT FIRST OUR QUALITY CONTROL LABORATORY CHECKED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IH-CARD ABD/D(DVI-)+REV A1,B. THE VISUAL INSPECTION FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER WAS PASSED WITHOUT ANY IRREGULARITIES. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. THEN THE QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES AND WITH THE PATIENT SAMPLES PROVIDED BY THE CUSTOMER ON THE IH-1000. AS THE REASON FOR THE COMPLAINT WERE FALSE POSITIVE REACTIONS IN THE ANTI-B AND THE CONTROL WELL,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653348 ↗
• MalfunctionJul 2, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF TWO PATIENT SAMPLES WITH THE ANTI-B WELL OF IH-CARD ABO/D(DVI-)+REV. A1, B, LOT: 9336010 ON THEIR IH-1000 INSTRUMENT. A 2+ RESPECTIVELY 3+ REACTION WAS OBTAINED IN THE ANTI-B WELL, BUT REVERSE TYPE INDICATED BLOOD GROUP A. AFTER REPETITION ON THE SAME INSTRUMENT THE CORRECT BLOOD TYPE (BLOOD GROUP A) WAS OBTAINED. THE CUSTOMER PROVIDED US FOUR (4) PATIENT SAMPLES, IH-CELL A1&B LOT 9418011, AND 12 CARDS OF IH-CARD ABD/D(DVI-)+REV A1,B, LOT 9336010 FOR INVESTIGATIONAL TESTING. AT FIRST OUR QUALITY CONTROL LABORATORY CHECKED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IH-CARD ABD/D(DVI-)+REV A1,B. THE VISUAL INSPECTION FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER WAS PASSED WITHOUT ANY IRREGULARITIES. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. THEN QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES AND WITH THE PATIENT SAMPLES PROVIDED BY THE CUSTOMER ON THE IH-1000. AS THE REASON FOR THE COMPLAINT WERE FALSE POSITIVE REACTIONS IN THE ANTI-B, THE FOCUS WAS ON THE TESTING OF BLOOD GROUP A AND O RHD-POSITIVE BLOOD SAMPLES. ALL PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653278 ↗
• MalfunctionMar 15, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF A PATIENT SAMPLE IN THE ANTI-B OF THE IH-CARD ABO/D(DVI-) + REV. A1, B ON IH-1000. THE PATIENT WAS HISTORICALLY TYPED AS BLOOD GROUP A. THE PATIENT SAMPLE ALSO SHOWED A POSITIVE REACTION IN THE CONTROL WELL OF THE IH-CARD ABO/D(DVI-)+REV. A1, B ON IH-1000. THE PATIENT SAMPLE SHOWED CORRECT RESULTS IN THE REVERSE TYPING ON THE IH-1000: THE REACTION WITH IH-CELL A1 WAS CORRECTLY NEGATIVE, WHILE THE REACTION WITH IH-CELL B WAS CORRECTLY POSITIVE. DUE TO THE POSITIVE REACTION IN THE CONTROL WELL AND THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING NO BLOOD GROUP TEST RESULT WAS RELEASED BY THE IH-1000. FURTHERMORE, THE CUSTOMER STATED THAT THE PATIENT SAMPLE SHOWED A POSITIVE RESULT IN THE DAT (DIRECT ANTIGLOBULIN TEST). THE CUSTOMER DID NEITHER RETURN A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED THE UNEXPECTED POSITIVE REACTIONS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, OUR QUALITY CONTROL LABORATORY VISUALLY CHECKED THE RETENTION SAMPLE FOR INTACT SEALING, CORRECT POSITION OF THE ALUMINIUM FOIL FLAPS, HOMOGENEOUS GEL, CORRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911925 ↗
• MalfunctionDec 12, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS RESPECTIVELY QUESTION MARK RESULTS OF PATIENT SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B WHEN USED ON THEIR IH-1000 INSTRUMENT. . THE CUSTOMER DID NEITHER PROVIDE A SAMPLE OF THE PRODUCT FOR INVESTIGATIONAL TESTIN NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY EXAMINED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. THE FOCUS OF THE TEST WAS ON RED BLOOD CELLS OF BLOOD GROUPS A AND O AS THE CUSTOMER HAD REPORTED FALSE POSITIVE REACTIONS IN ANTI-B. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. TRACE FILES OF THE AFFECTED IH-1000 WERE INVESTIGATED. FOR A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310591 ↗
• MalfunctionDec 12, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS RESPECTIVELY QUESTION MARK RESULTS OF PATIENT SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B WHEN USED ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER DID NEITHER PROVIDE A SAMPLE OF THE PRODUCT FOR INVESTIGATIONAL TESTIN NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY EXAMINED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. THE FOCUS OF THE TEST WAS ON RED BLOOD CELLS OF BLOOD GROUPS A AND O AS THE CUSTOMER HAD REPORTED FALSE POSITIVE REACTIONS IN ANTI-B. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. TRACE FILES OF THE AFFECTED IH-1000 WERE INVESTIGATED. FOR ALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310590 ↗
• MalfunctionNov 27, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS OF IH-CARD ABO/D(DVI-)+REV. A1, B WITH IH-BASIC QC AND PATIENT SAMPLES ON THEIR IH-500 INSTRUMENT. THE CUSTOMER STATED THAT THE CONTROL WELL, THE ANTI-A, THE ANTI-B AND THE ANTI-D WERE AFFECTED. THE CUSTOMER DID NOT YET RETURN A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THEIR RETENTION SAMPLE REGARDING INTACT SEALING, CORRECT FILLING HEIGHT, HOMOGENEOUS GEL, AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. ADDITIONALLY, THE RETENTION SAMPLE WAS TESTED ON THE IH-500. IH-BASIC QC AND THE FOLLOWING DONOR SAMPLES WERE USED FOR THIS PURPOSE: 3 X BLOOD GROUP O RHD POSITIVE, 3 X BLOOD GROUP B RHD POSITIVE, 3 X BLOOD GROUP A RHD POSITIVE, 2 X BLOOD GROUP O RHD NEGATIVE, 3 X BLOOD GROUP A RHD NEGATIVE AND 2 X BLOOD GROUP B RHD NEGATIVE. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. FURTHERMORE, SEVEN CARDS WERE OPENED MANUALLY, AND THE SEALING FOIL EXAMINED FOR POSSIBLE GEL AND / OR ANTISERUM SPLASHES. WE DID NOT OBSERVE ANY SPLASHES ON THE FOIL. A REVIEW OF THE B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209057 ↗
• MalfunctionNov 23, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF ONE PATIENT SAMPLE WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE PATIENT HISTORICALLY HAD THE BLOOD GROUP A RHD POSITIVE. A REPEAT TESTING ON THE SAME INSTRUMENT AND IN THE TUBE TEST WAS CONSISTENT WITH THE PATIENT'S HISTORICAL BLOOD GROUP. THE CUSTOMER DID NEITHER PROVIDE A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE POSITIVE TEST RESULT. THEREFORE, OUR QUALITY CONTROL LABORATORY INVESTIGATED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. DATA FILES OF THE AFFECTED IH-1000

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18197269 ↗
• MalfunctionNov 9, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF A PATIENT SAMPLE WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV. A1, B ON IH-1000. THE CUSTOMER STATED THAT THE PATIENT SAMPLE HAS HISTORICALLY BEEN TYPED AS BLOOD GROUP O RH(D) POSITIVE. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED THE FALSE POSITIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY INVESTIGATED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THE RETENTION SAMPLE FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. THEN OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION IN THE ANTI-B WELL. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE TRACE FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE REQUESTED. THE INVESTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099047 ↗
• MalfunctionJul 26, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF EIGHT PATIENT SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. TRACE FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE COLLECTED AND THE INSTRUMENT CHECKED BY ONE OF OUR FIELD SERVICE ENGINEERS. INVESTIGATION OF THE FILES SHOWED THAT ALL PATIENT SUSPENSIONS WERE DISPENSED FROM WELL 4 TO WELL 1 AND ALSO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395751 ↗
• MalfunctionJul 26, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF PATIENT SAMPLES WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE INVESTGATION OF THE AFFECTED IH-1000 INSTRUMENT IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395713 ↗
• MalfunctionJul 11, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A SAMPLE WITH THE ANTI-D OF IH-CARD ABO/D(DVI-)+REV A1, B ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE PATIENT WAS TYPED AS WEAK D IN (B)(6) 2019. THE CUSTOMER DID NEITHER RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED THE FALSE NEGATIVE TEST RESULT. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. AMONG OTHERS, TWO DIFFERENT WEAK D DONOR SAMPLES WERE TESTED. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. BOTH WEAK D SAMPLES SHOWED POSITIVE RESULTS WITH THE ANTI-D OF IH-CARD ABO/D(DVI-)+REV. A1, B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE INSTRUMENT DATA AND THE LOG FILES OF THE AFFECTED IH-1000 WERE REVIEWED. THE EVALUATION OF THE DATA SHOWS THAT THE INTERPRETATION OF THE ANTI-D WELL AS NEGATIVE WAS JUSTIFIED. THE VOLUME DISPENSED OF THE RED BLOOD SUSPENSION IN THE WELLS LOOK REGULAR AND WITHIN THE RANGE. NO ERROR MESSAGE WAS IDENTIFIED DURING THE TEST. DIFFERENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296986 ↗
• MalfunctionJul 11, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A SAMPLE WITH THE ANTI-D OF IH-CARD ABO/D(DVI-)+REV A1, B ON THEIR IH-1000 INSTRUMENT. THE PATIENT WAS RESTED IN 2019 AND YIELDED AT THAT TIME A WEAK D RESULT. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY STARTED TESTING THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THIS TESTING IS STILL ONGOING. THE BATCH RECORD DOCUMENTATION WAS REVIEWED AND SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE INVESTIGATION OF THE INSTRUMENT DATA OF THE AFFECTED IH-1000 IS ALSO STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296984 ↗
• MalfunctionMay 24, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF A PATIENT SAMPLE WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV. A1, B ON ONE IH-1000 INSTRUMENT. THE CUSTOMER RETESTED ON SAME IH-1000 AND IN TUBE AND THE RESULTS MATCHED THE HISTORIC TYPE OF BLOOD GROUP O. THE CUSTOMER NEITHER PROVIDED A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE POSITIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE. FIRST, OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. THEN THE QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES AND WITH A FOCUS ON B-ANTIGEN NEGATIVE/D-ANTIGEN POSITIVE TEST SAMPLES ON IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION IN THE ANTI-B WELL A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991980 ↗
• MalfunctionMay 23, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT TWO SAMPLES FROM ALLEGEDLY ONE PATIENT SHOWED DIFFERENT BLOOD GROUPS ON IH-CARD ABO/D(DVI-)+REV. A1, B WHEN TESTED ON THE IH-1000 INSTRUMENT: ON (B)(6) 2023, SAMPLE ACC # (B)(4) WAS PERFORMED ON IH-1000 SN (B)(6) AND TYPED AS B RHD NEGATIVE. ON (B)(6) 2023, SAMPLE ACC # (B)(4) WAS PERFORMED ON IH-1000 SN (B)(6) AND TYPED AS A RHD POSITIVE. THE CUSTOMER STATED THAT BOTH SAMPLES BELONGED TO THE SAME PATIENT WITH THE SAME DOB (DATE OF BIRTH) AND NAME. THE CUSTOMER DID NEITHER PROVIDE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT IH-CARD ABO/D(DVI-)+REV. A1, B FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT CAUSED THE DISCREPANT RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH KNOWN DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY DISCREPANCIES. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. BECAUSE OF THE MISSING INFORMATION REGARDING THE PATIENT SAMPLES IN QUESTION A MORE IN-DEPTH ANALYSIS WAS NOT POSSIBLE. THE CUSTOMER INFORMED US THAT THEY WERE NOT SURE WHAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982568 ↗