Erytype® S ABD+Rev. A1,B 806127100Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 07611969951147), received between Sep 14, 2016 and Aug 21, 2023 — classified as 30 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (18 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN UNEXPECTED WEAK POSITIVE REACTION OF ONE PATIENT SAMPLE WITH THE ANTI-D (CLONE 232) OF ERYTYPE S ABD+REV. A1, B ON TANGO INFINITY. THE CUSTOMER PROVIDED IMAGES OF THE TANGO INFINITY WHICH SHOWED A WEAK POSITIVE REACTION WITH THE ANTI-D 232, WHILE THE REACTION WITH ANTI-D 226 WAS NEGATIVE. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE OF ERYTYPE S ABD+REV. A1, B FOR INVESTGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED THE REACTION IN QUESTION. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON THE TANGO INFINITY. 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 INVESTIGATION OF THE AFFECTED TANGO INFINITY INSTRUMENT SHOWED NO INDICATION FOR A MALFUNCTION OF THE INSTRUMENT. REVIEWED WERE THE FIELD SERVICE REPORT // FIELD SERVICE NOTES AND METROLOGY CERTIFICATE AND FURTHER RECEIVED RELEVANT INFORMATION. ALSO, THE DATA BASES AND THE INSTRUMENT'S LOG FILES WERE REVIEWE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17582698 ↗
• MalfunctionFeb 23, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE PATIENT SAMPLE WITH BOTH ANTI-D CLONES (CLONE (B)(6)) OF ERYTYPE S ABD+REV. A1, B WHEN TESTED ON TANGO INFINITY. THE CUSTOMER DID NEITHER RETURN THE PRODUCT SAMPLE OF ERYTYPE S ABD+REV. A1, B FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD 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 TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION OF A RHD POSITIVE SAMPLE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. RESULT IMAGES WERE PROVIDED THAT SHOW NEGATIVE RESULTS FOR RH(D), AND ALSO A GRAINY COLORING IN THE WELL. A FILED SERVICE ENGINEER WAS AT THE CUSTOMER'S SITE TO COLLECT LOG FILES OF THE AFFECTED TANGO INFINITY INSTRUMENT. THE RECEIVED DATABASES AND LOG FILES WERE ANALYZED FOR ANY ISSUE RELEVANT ANOMALIES. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES. BASED ON CURRENT INFORMATION AND DATA THERE IS NO INDICATION F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583063 ↗
• MalfunctionFeb 23, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE PATIENT SAMPLE WITH BOTH ANTI-D CLONES (CLONE (B)(6)) OF ERYTYPE S ABD+REV. A1, B WHEN TESTED ON TANGO INFINITY. THE CUSTOMER DID NEITHER RETURN THE PRODUCT SAMPLE OF ERYTYPE S ABD+REV. A1, B FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD 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 TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION OF A RHD POSITIVE SAMPLE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. RESULT IMAGES WERE PROVIDED THAT SHOW NEGATIVE RESULTS FOR RH(D), AND ALSO A GRAINY COLORING IN THE WELL. A FILED SERVICE ENGINEER WAS AT THE CUSTOMER'S SITE TO COLLECT LOG FILES OF THE AFFECTED TANGO INFINITY INSTRUMENT. THE RECEIVED DATABASES AND LOG FILES WERE ANALYZED FOR ANY ISSUE RELEVANT ANOMALIES. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES. BASED ON CURRENT INFORMATION AND DATA THERE IS NO INDICATION F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583061 ↗
• MalfunctionFeb 1, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS IN THE ANTI-B OF ERYTYPE S ABD+REV. A1, B WHEN USED ON TANGO INFINITY. THE CUSTOMER STATED THAT THE ISSUE OCCURRED SPORADICALLY WITHOUT PROVIDING MORE THAN ONE DATE OF EVENT. THE CUSTOMER PROVIDED TANGO IMAGES WHICH SHOWED WEAK POSITIVE REACTIONS IN THE ANTI-B. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE ERYTYPE S ABD+REV.A1, B 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 ALLEGEDLY DEFECTIVE LO WITH DIFFERENT DONOR SAMPLES ON TANGO INFINITY. 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. REGARDING THE AFFECTED TANGO INFINITY, THE CUSTOMER PROVIDED RESULT IMAGES THAT SHOW WEAK (1+) POSITIVE RESULTS IN THE ANTI-B WELL (FORWARD TESTING) THAT IS DISCREPANT TO THE REVERSE TESTING. THE INSTRUMENT'S SOFTWARE MARKED THESE RESULTS AS DISCREPANT, AND NO FALSE RESULT WAS RELEASED. THE POSITIVE RESULT OCCURRED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415648 ↗
• MalfunctionJan 17, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF TWO PATIENT SAMPLES WITH BOTH ANTI-D REAGENTS OF ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT EACH ISSUE OCCURRED ONLY ONCE. IN THE REPEAT TESTING, THE MANUAL TESTING, AND IN ONE CASE THE TESTING ON THE OTHER TANGO INFINITY THE RESULTS WITH BOTH ANTI-D REAGENTS WERE CORRECTLY POSITIVE. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE, BUT TWO PATIENT SAMPLES THAT CAUSED THE FALSE NEGATIVE TEST RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THE TESTING WAS DONE WITH DIFFERENT RH(D) POSITIVE AND NEGATIVE DONOR SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. FURTHERMORE, THE PATIENT SAMPLES WERE TESTED WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND THE REFERENCE LOT ON TANGO INFINITY. BOTH PATIENT SAMPLES YIELDED CLEARLY POSITIVE RESULTS ON BOTH ERYTYPE S ABD+REV. A1, B PLATES. THE CUSTOMER PROVIDED RESULT IMAGES THAT SHOW ON (B)(6) 2021 THE NEGATIVE RESULT FOR BOTH RH CLONES AND ON REPEAT TESTING ON (B)(6) 2021 STRONG 4+ POSITIVE RESULTS FOR BOTH RH CLON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266056 ↗
• MalfunctionDec 9, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A PATIENT SAMPLE WITH THE ANTI-B OF ERYTYPE S ABD+REV.A1, B WHEN USED ON TANGO INFINITY. THE CUSTOMER STATED THAT THE REACTION LOOKED LIKE MIXED FIELD. THE CUSTOMER PROVIDED THE COMPLAINT SAMPLE AND ALSO THE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE WITH DONOR SAMPLES AND THE PATIENT SAMPLE PROVIDED BY THE CUSTOMER ON TANGO INFINITY. THE DONOR SAMPLES SHOWED CORRECTLY POSITIVE AND NEGATIVE REACTIONS. THE PATIENT SAMPLE COULD NOT BE CORRECTLY EVALUATED BY THE TANGO INSTRUMENT BECAUSE THE AMOUNT OF PIPETTED RED BLOOD CELLS WAS INSUFFICIENT. A REPEAT TESTING WAS NOT POSSIBLE, BECAUSE THE COMPLAINT SAMPLE WAS USED UP. OUR QUALITY CONTROL LABORATORY HAD TESTED THE SAME DONOR SAMPLES AND THE PATIENT SAMPLE WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON TANGO INFINITY. AGAIN, THE DONOR SAMPLES SHOWED THE CORRECT POSITIVE AND NEGATIVE REACTIONS. THE PATIENT SAMPLE SHOWED A VERY SMALL AGGLUTINATE WITH THE ANTI-B WHICH WAS ASSESSED AS NEGATIVE BY THE INSTRUMENT. ADDITIONALLY, THE PATIENT SAMPLE WAS TESTED WITH SERACLONE ANTI-B IN THE TUBE TEST (IMMEDIATE SPIN) AND SHOWE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967449 ↗
• MalfunctionNov 23, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF TWO PATIENT SAMPLES WITH BOTH ANTI-D REAGENTS OF ERYTYPE S ABD+REV.A1, B WHEN USED ON TANGO INFINITY. THE CUSTOMER STATED THAT EACH OF THE TWO FALSE NEGATIVE RESULTS WERE A SINGULAR EVENT AND OCCURRED ONLY ONCE. WHEN RETESTED MANUALLY AND IN ONE CASE ON A SECOND TANGO INFINITY AT THE CUSTOMER'S SITE, THE RESULTS WITH BOTH ANTI-D REAGENTS WERE CORRECTLY POSITIVE. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE OF ERYTYPE S ABD+REVA1,B FOR INVESTIGATIONAL TESTING, BUT THE TWO PATIENT SAMPLES THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT OF ERYTYPE ABD+REVA1,B. DIFFERENT RH(D) POSITIVE AND NEGATIVE DONOR SAMPLES WERE TESTED ON TANGO INFINITY AND ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. FURTHERMORE, THE PATIENT SAMPLES WERE ALSO TESTED WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND A REFERENCE LOT ON TANGO INFINITY. BOTH PATIENT SAMPLES YIELDED CLEARLY POSITIVE RESULTS ON BOTH ERYTYPE S ABD+REV. A1, B PLATES. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12859458 ↗
• MalfunctionJun 2, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT A DONOR SAMPLE SHOWED A FALSE NEGATIVE RESULT WITH ANTI-D OF ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT THE DONOR SAMPLE SHOULD BE USED AS A O RHD NEGATIVE CONTROL BUT IT SHOWED A WEAK POSITIVE REACTION WITH THE ANTI-D OF ERYTYPE RH CONFIRM ON TANGO INFINITY. BASED ON THIS RESULT THE CUSTOMER TESTED THE DONOR SAMPLE WITH SERACLONE ANTI-D BLEND IN THE TUBE TECHNIQUE. THE SAMPLE SHOWED A NEGATIVE "RESULT" IN THE IMMEDIATE SPIN TEST, BUT A POSITIVE RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT). THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ERYTYPE S ABD+REV.A1, B, BUT THE DONOR SAMPLE (#(B)(6)) THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THE DONOR SAMPLE WAS SEPARATED IN PLASMA AND RED BLOOD CELLS. ADDITIONALLY, THE CUSTOMER RETURNED SERACLONE ANTI- D BLEND. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR SAMPLE WITH THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1, B AND COULD CONFIRM THE CUSTOMER´S FINDING. ADDITIONALLY, THE DONOR SAMPLE WAS TESTED WITH SERACLONE ANTI-D BLEND IN THE TUBE TECHNIQUE. AGAIN, THE CUSTOMER´S FINDING COULD BE CONFIRMED: A NEGATIVE RESULT IN THE IMMEDIATE SPIN TEST, BUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921238 ↗
• MalfunctionJun 2, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT A DONOR SAMPLE SHOWED A FALSE NEGATIVE RESULT WITH ANTI-D OF ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT THE DONOR SAMPLE SHOULD BE USED AS A O RHD NEGATIVE CONTROL BUT IT SHOWED A WEAK POSITIVE REACTION WITH THE ANTI-D OF ERYTYPE RH CONFIRM ON TANGO INFINITY. BASED ON THIS RESULT THE CUSTOMER TESTED THE DONOR SAMPLE WITH SERACLONE ANTI-D BLEND IN THE TUBE TECHNIQUE. THE SAMPLE SHOWED A NEGATIVE RESULLT IN THE IMMEDIATE SPIN TEST, BUT A POSITIVE RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT). THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ERYTYPE S ABD+REV.A1, B, BUT THE DONOR SAMPLE (#2308048) THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THE DONOR SAMPLE WAS SEPARATED IN PLASMA AND RED BLOOD CELLS. ADDITIONALLY, THE CUSTOMER RETURNED SERACLONE ANTI- D BLEND. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR SAMPLE WITH THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1, B AND COULD CONFIRM THE CUSTOMER´S FINDING. ADDITIONALLY, THE DONOR SAMPLE WAS TESTED WITH SERACLONE ANTI-D BLEND IN THE TUBE TECHNIQUE. AGAIN, THE CUSTOMER´S FINDING COULD BE CONFIRMED: A NEGATIVE RESULT IN THE IMMEDIATE SPIN TEST, BUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921234 ↗
• MalfunctionJun 2, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT A DONOR SAMPLE SHOWED A FALSE NEGATIVE RESULT WITH ANTI-D OF ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT THE DONOR SAMPLE SHOULD BE USED AS A O RHD NEGATIVE CONTROL. BUT THEN THE DONOR SAMPLE SHOWED A WEAK POSITIVE REACTION WITH THE ANTI-D OF ERYTYPE RH CONFIRM ON TANGO INFINITY. BASED ON THIS RESULT THE CUSTOMER TESTED THE DONOR SAMPLE WITH SERACLONE ANTI-D BLEND IN THE TUBE TECHNIQUE. THE SAMPLE SHOWED A NEGATIVE RESULLT IN THE IMMEDIATE SPIN TEST, BUT A POSITIVE RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT). THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ERYTYPE S ABD+REV.A1, B, BUT THE DONOR SAMPLE ((B)(6)) THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THE DONOR SAMPLE WAS SEPARATED IN PLASMA AND RED BLOOD CELLS. ADDITIONALLY, THE CUSTOMER RETURNED SERACLONE ANTI- D BLEND. OUR QUALITY CONTROL LABORATORY TESTED THE DONOR SAMPLE WITH THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1, B AND COULD CONFIRM CUSTOMER´S FINDING. ADDITIONALLY, THE DONOR SAMPLE WAS TESTED WITH SERACLONE ANTI-D BLEND IN THE TUBE TECHNIQUE. AGAIN, THE CUSTOMER´S FINDING COULD BE CONFIRMED: A NEGATIVE RESULT IN THE IMMEDIATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921233 ↗
• MalfunctionApr 30, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SHOWED A FALSE NEGATIVE RH(D) RESULT WHEN THE SAMPLE WAS TESTED USING ERYTYPE S ABD+REV A1,B ON TANGO INFINITY. THE PATIENT HAD BEEN TESTED RH(D) POSITIVE ON TANGO OPTIMO THE PREVIOUS YEAR. THE RH(D) POSITIVE RESULT WAS NOW CONFIRMED BY ANOTHER LABORATORY. THE CUSTOMER RETURNED NEITHER THE COMPLAINT SAMPLE ERYTYPE S ABD+REV.A1, B FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD 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 TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. REGARDING THE AFFECTED TANGO INFINITY: THE CUSTOMER PROVIDED A BLACK/WHITE RESULT IMAGE OF POOR QUALITY THAT SHOWS A NEGATIVE REACTION FOR BOTH ANTI-D WELLS. THE LAST PREVENTATIVE MAINTENANCE DATE WAS ON (B)(6) 2021 AND THE SERVICE ENGINEER CONFIRMED A PROPER FUNCTION OF THE INSTRUMENT. THE QC WAS RUN AND PASSED ALL REQUIREMENTS. DUE TO THE MISSING SAMPLES, THE NEGATIVE RESULTS AT CUSTOMER´S SITE REMAINED UNKNOWN. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753731 ↗
• MalfunctionMar 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED SOME DOTS OR RESIDUALS IN THE WELLS OF ERYTYPE S ABD+REV.A1, B. THE OBSERVED DOTS CAUSED FALSE POSITIVE RESULTS ON TANGO INFINITY. BECAUSE THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE OF ERYTYPE S ABD+REVA1,B FOR INVESTIGATINAL TESTING, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND ERYTYPECELL A1&B LOT #9102011-00 AND #9106011-00 WITH DIFFERENT DONOR SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY DOTS OR RESIDUALS. ALL NEGATIVE REACTIONS WERE CLEARLY NEGATIVE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO INFINITY WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS. THE INFORMATION PROVIDED BY THE FIELD SERVICE ENGINEER CONFIRMED THAT THE INSTRUMENT WAS WITHIN MANUFACTURER MEANS AND WAS RETURNED TO THE CUSTOMER FOR NORMAL USE. ACCORDING TO THE FIELD SERVICE ENGINEER, THE CUSTOMER LET THE ERYTYPE PLATES NOT COME TO ROOM TEMPERATURE BEFORE LOADING ON THE INSTRUMENT. THE CUSTOMER WAS INFORMED THAT THEY SHOULD LET THE PLATES COME TO ROOM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403340 ↗
• MalfunctionFeb 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FAILED PATIENT BLOOD GROUPS WHEN USING ERYPECE S ABD+REV A1,B ON TANGO OPTIMO, BECAUSE THERE WAS A "GOB" IN THE REVERSE A1 CELLS WHICH THE TANGO INTERPRETED AS POSITIVE. HE CONFIRMED THAT THE TANGO OPTIMO IS FUNCTIONING PROPERLY. THE CUSTOMER MENTIONED THAT HE RECEIVED THE AFFECTED PRODUCT IN BOXES THAT WERE DAMAGED AND THE PLATES HE RECEIVED WERE WET. THESE CONDITIONS SHOULD NOT HAVE A NEGATIVE IMPACT TO THE QUALITY OF THE ERYTYPE PLATES, BECAUSE THEY ARE SEALED IN A SPECIAL ALUMINUM FOIL WHICH IS IMPERMEABLE TO WATER VAPOR. A NEGATIVE IMPACT CANNOT BE EXCLUDED IN CASE THE SEALING OF THE PLATES WAS DAMAGED. IN ORDER TO EXCLUDE A DAMAGING OF THE SEALING THE CUSTOMER WAS ENCOURAGED TO RETURN THE PLATES FOR INVESTIGATION. THE CUSTOMER DID NOT PROVIDE THE AFFECTED PLATES FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ERYTYPE S ABD+REV.A1, B WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT SEE ANY CLUMPS IN THE REVERSE TYPING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364515 ↗
• MalfunctionFeb 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FAILED PATIENT BLOOD GROUPS WHEN USING ERYPECE S ABD+REV A1,B ON TANGO OPTIMO, BECAUSE THERE WAS A "GOB" IN THE REVERSE A1 CELLS WHICH THE TANGO INTERPRETED AS POSITIVE. HE CONFIRMED THAT THE TANGO OPTIMO IS FUNCTIONING PROPERLY. THE CUSTOMER MENTIONED THAT HE RECEIVED THE AFFECTED PRODUCT IN BOXES THAT WERE DAMAGED AND THE PLATES HE RECEIVED WERE WET. THESE CONDITIONS SHOULD NOT HAVE A NEGATIVE IMPACT TO THE QUALITY OF THE ERYTYPE PLATES, BECAUSE THEY ARE SEALED IN A SPECIAL ALUMINUM FOIL WHICH IS IMPERMEABLE TO WATER VAPOR. A NEGATIVE IMPACT CANNOT BE EXCLUDED IN CASE THE SEALING OF THE PLATES WAS DAMAGED. IN ORDER TO EXCLUDE A DAMAGING OF THE SEALING THE CUSTOMER WAS ENCOURAGED TO RETURN THE PLATES FOR INVESTIGATION. THE CUSTOMER DID NOT PROVIDE THE AFFECTED PLATES FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ERYTYPE S ABD+REV.A1, B WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT SEE ANY CLUMPS IN THE REVERSE TYPING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364512 ↗
• MalfunctionDec 16, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT THE BLOOD GROUP OF SIX PATIENT SAMPLES FAILED ON TANGO OPTIMO. THE RESULTS FAILED BECAUSE OF SO CALLED "GLOBS" IN THE REVERSE TYPING. THE CUSTOMER STATED THAT THIS ISSUE OCCURRED WITH ERYTYPE S ABD +REV A1B AND ERYTYPECELL A1 AND DUE TO THE GLOBS THE REACTION WERE EVALUATED AS POSITIVES. THE IMAGES PROVIDED BY THE CUSTOMER SHOWED THAT THE NEGATIVE REACTIONS WITH ERYTYPECELL A1 WERE NOT COMPLETELY RESUSPENDED AND THEREFORE AS POSITIVE REACTIONS RATED. BECAUSE THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY INCOMPLETELY RESUSPENDED NEGATIVE REACTIONS. THE CUSTOMER PROVIDED RESULT IMAGES THAT SHOW AN ARTIFACT IN THE A1 CELL OF REVERSE TYPING, WHICH LEADS THE INSTRUMENTS RESULT INTERPRETATION SOFTWARE TO CALCULATE A POSITIVE RESULT (2+) INSTEAD OF A NEGATIVE FOLLOWING A DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING. THE DISCREPANCY IS VISIBLE TO THE CUSTOMER BY SHOWING UP THE DISCREPANCY FLAG AND QUESTION MARKS IN THE OVERALL RESULT FIELD. NO FALSE RESULT WAS SHOWN BY THE INSTRU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11018553 ↗
• MalfunctionJul 11, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE (B)(6) WAS TYPED AS BLOOD GROUP AB IN THE FORWARD TESTING AND TYPED AS BLOOD GROUP A IN THE REVERSE TYPING. THE CUSTOMER USED ERYTYPE S ABD+REV.A1,B ON TANGO OPTIMO. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT ERYTYE S ABD+REV.A1,B FOR INVESTIGATIONAL TESTING BUT THE PATIENT SAMPLE. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1, B WITH THE PATIENT SAMPLE ON TANGO OPTIMO. SAMPLE (B)(6) YIELDED BLOOD GROUP A RH(D) POSITIVE. THE CORRECTNESS OF THE TYPED BLOOD GROUP OF THE SAMPLE WAS ADDITIONALLY CONFIRMED IN THE GEL CARD METHOD. IN ALL TESTS OF QUALITY CONTROL LABORATORY THE FORWARD AND THE REVERSE TYPING OF THE PATIENT SAMPLE MATCHED. WE DID NOT OBSERVE ANY DISCREPANCIES BETWEEN FORWARD AND REVERSE TYPING. ADDITIONALLY OUR QC LAB'S RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1,B WAS TESTED WITH DIFFERENT DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESPECTIVELY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S ABD+REV.A1, B FUNCTIONS CORRECTLY. A REVIE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7676750 ↗
• MalfunctionJul 11, 2018Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH THE HISTORICAL BLOOD GROUP O RH(D) POSITIVE (SAMPLE (B)(6)) WAS TYPED AS B RH(D) NEGATIVE USING ERYTYPE S ABD+REV.A1, B ON TANGO OPTIMO. THE CUSTOMER REPEATED THE SAME SAMPLE (B)(6) ON THE SAME TANGO OPTIMO AND THE PATIENT WAS CORRECTLY TYPED AS O RH(D) POSITIVE. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT ERYTYE S ABD+REV.A1,B FOR INVESTIGATIONAL TESTING BUT THE PATIENT SAMPLE. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1, B WITH THE PATIENT SAMPLE ON TANGO OPTIMO. SAMPLE #051785 YIELDED BLOOD GROUP O RH(D) POSITIVE. THE CORRECTNESS OF THE TYPED BLOOD GROUP OF THE SAMPLE WAS ADDITIONALLY CONFIRMED IN THE GEL CARD METHOD. IN ALL TESTS OF QUALITY CONTROL LABORATORY THE FORWARD AND THE REVERSE TYPING OF THE PATIENT SAMPLE MATCHED. WE DID NOT OBSERVE ANY DISCREPANCIES BETWEEN FORWARD AND REVERSE TYPING. ADDITIONALLY OUR QC LAB'S RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1,B WAS TESTED WITH DIFFERENT DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESPECTIVELY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABOR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7676747 ↗
• MalfunctionOct 6, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A PATIENT SAMPLE WHEN TESTED WITH ANTI-A ON ERYTYPE S ABD+REV.A1, B ON TANGO OPTIMO. THE RESULT WITH ANTI-B WAS CORRECTLY POSITIVE. THE CUSTOMER TESTED THE PATIENT SAMPLE IN THE TUBE TECHNIQUE AND YIELDED A POSITIVE RESULT WITH ANTI-A. THE CUSTOMER FURTHER STATED THAT PATIENT WAS HISTORICALLY TYPED AS BLOODGROUP AB. THE CUSTOMER RETURNED THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT FOR INVESTIGATIONAL TESTING AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT. OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE COMPLAINT SAMPLE OF ERYTYPE S ABD+REV.A1, B ON TANGO OPTIMO AND COULD CONFIRM THE CUSTOMER´S FINDING: THE PATIENT SAMPLE YIELDED A NEGATIVE REACTION WITH ANTI-A ON ERYTYPE S ABD+REV.A1, B, BUT A POSITIVE REACTION WITH ANTI-B. OUR QUALITY CONTROL LABORATORY ALSO TESTED THE PATIENT SAMPLE IN THE TUBE TECHNIQUE. THE RESULTS INDICATE BLOOD GROUP B AND NOT AB DUE TO THE REACTIONS OF SERUM GROUPING. THE SAMPLE WAS SENT FOR MOLECULAR ABO BLOOD GROUP TYPING TO AN EXTERNAL LABORATORY. THE RESULT OF THE EXTERNAL INVESTIGATION WAS BLOOD GROUP AB. THE COMPLAINT SAMPLE AS WELL AS OUR QC LAB'S RETENTION SAMPLE WERE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6921493 ↗
• MalfunctionSep 8, 2017False Negative Result; Defective Component

  THE CUSTOMER REPORTED THAT ONE KNOWN RH POSITIVE PATIENT SAMPLE SHOWED FALSE NEGATIVE TEST RESULTS FOR ANITI-D WITH ERYTYPE S ABD + REV. A1,B WHEN TESTED ON TWO DIFFERENT TANGO OPTIMOS. THE CUSTOMER STATED THAT AN EVIDENCE OF LITTLE GRANULARITY IN THE WELLS CAN BE SEEN VISUALLY ON THE IMAGE. THE CUSTOMER RETURNED THE SAMPLE THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT (TWO PLATES OF ERYTYPE S ABD+REV.A1, B). THE PATIENT SAMPLE RETURNED FROM THE CUSTOMER COULD NOT BE TESTED BECAUSE THE RED BLOOD CELLS WERE HEMOLYZED AND THEY HAVE A VISCOUS CONSISTENCY, SO THE PATIENT SAMPLE WAS SENT FOR MOLECULAR BIOLOGICAL INVESTIGATION. THEREFORE OUR QUALITY CONTROL TESTED DIFFERENT DONOR SAMPLES WITH THE COMPLAINT RETURNED PRODUCTS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. MOLECULAR BIOLOGICAL INVESTIGATION OF THE PATIENT SAMPLE YIELDED THE FOLLOWING RESULT: CCD.EE WEAK D TYPE 1 TO 5, 11, 14, 15, 17 NEGATIVE. SEQUENCING OF BOTH SAMPLES SHOWS IDENTICAL POLYMORPHISM IN THE NON-CODING AREAS OF THE RHD-GENE. THERE IS AN INTRON-8 MUTATION. THE IMPACT OF THIS MUTATION CANNOT BE EASILY CLASSIFIED: IT HAS B

  Patient problems: Hemolysis

  MAUDE report 6851122 ↗
• MalfunctionSep 4, 2017False Negative Result

  THE CUSTOMER REPORTED THAT ONE PATIENT SAMPLE KNOWN AS B RH(D) POSITIVE SHOWED FALSE NEGATIVE REACTIONS WITH ANTI-D OF ERYTYPE S ABD+REV. A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT THE PATIENT HAS BEEN TRANSFUSED WITH ONE UNIT OF O RH(D) NEGATIVE AND ONE UNIT OF B RH(D) NEGATIVE BLOOD CELLS. THE PATIENT SAMPLE RAN ON THE TANGO INFINITY TWICE POST THE TRANSFUSION. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE SHOWED A POSITIVE REACTION (4+/ MIXED FIELDS) WITH ANTI D IN TUBE TESTING. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE LOT OF THE PRODUCT ERYTYPE S ABD + REV. A1,B AND THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULTS (DATE OF RECEIPT 08/29/2017) . THE INVESTIGATIONS OF OUR QUALITY CONTROL LABORATORY ARE STILL ONGOING. FROM TODAY´S PERSPECTIVE THE AFFECTED TANGO INFINITY WAS CONFIRMED TO RUN WITHIN SPECIFICATIONS. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES ON THE DATES OF TESTING, THE ROOT CAUSE ANALYSIS IS STILL ONGOING.

  Patient problems: No Code Available

  MAUDE report 6840945 ↗
• MalfunctionSep 4, 2017False Negative Result

  THE CUSTOMER REPORTED THAT ONE PATIENT SAMPLE KNOWN AS B RH(D) POSITIVE SHOWED FALSE NEGATIVE REACTIONS WITH ANTI-D OF ERYTYPE S ABD+REV. A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT THE PATIENT HAS BEEN TRANSFUSED WITH ONE UNIT OF O RH(D) NEGATIVE AND ONE UNIT OF B RH(D) NEGATIVE BLOOD CELLS. THE PATIENT SAMPLE RAN ON THE TANGO INFINITY TWICE POST THE TRANSFUSION. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE SHOWED A POSITIVE REACTION (4+/ MIXED FIELDS) WITH ANTI D IN TUBE TESTING. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED FALSE NEGATIVE RESULTS. OUR QUALITY CONTROL LABORATORY TESTED AS FOLLOWS: THE ALLEGEDLY DEFECTIVE PLATES WERE TESTED WITH DIFFERENT DONOR SAMPLES AND THE PROVIDED PATIENT SAMPLE (#: (B)(6)) ON TANGO INFINITY. ADDITIONALLY, A DWEAK TYP 3 SAMPLE WAS TESTED. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. UPON ARRIVAL AT BIO-RAD, THE PATIENT SAMPLE WAS ALREADY HEMOLIZED BUT IT WAS CLEARLY IDENTIFIED AS B RH(D) POSITIVE. PLATE 023963 (S ABD REV.A1,B) YIELDED 4+ REACTIONS WITH BOTH ANTI-D´S, PLATE 0961 (S RHD CONFIRM) YIELDED A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6840944 ↗
• MalfunctionApr 26, 2017False Positive Result

  THE CUSTOMER REPORTED THAT FIBRIN WAS PRESENT IN REVERSE TYPING OF A FEW SAMPLES WITH ERYTYPE S ABD+REV.A1, B ON TANGO OPTIMO. CUSTOMER STATED THAT DUE TO THE FIBRIN NEGATIVE REACTIONS OF REVERSE TYPING WERE FALSE POSITIVE. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT, BUT NOT THE PATIENT SAMPLES THAT HAD CAUSED FALSE POSITIVES. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE OF ERYTYPE S ABD+REV.A1, B WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ONLY IN ONE CASE THE NEGATIVE RESULT IN REVERSE TYPING WAS NOT COMPLETELY RESUSPENDED. VISUALLY ASSESSED IT WAS CLEARLY A NEGATIVE REACTION. ERYTYPE S ABD+REV.A1, B IS A MICROTEST PLATE READY FOR USE FOR ABO BLOOD GROUP TYPING. THE WELLS FOR THE ANTIGEN TYPING (FORWARD TESTING) CONTAIN DRIED MONOCLONAL ANTIBODIES. THE WELLS FOR THE REVERSE TYPING DO NOT CONTAIN ANY SERA OR REAGENTS, THE WELLS ARE EMPTY. DURING THE PROCESSING OF THE ERYTYPE S ABD+REV.A1, B, THE DONOR SAMPLES AND REAGENT RED BLOOD CELLS ARE PIPETTED INTO THE WELLS OF THE REVERSE TYPING. RED CELLS OF DONORS AND PATIENTS ARE PIPETTED INTO THE WELLS FOR THE FORWARD TESTING. TESTING BY OUR QUALITY CONTROL LA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6521573 ↗
• MalfunctionApr 5, 2017False Negative Result; Defective Device

  THE CUSTOMER REPORTED THAT A CORD BLOOD SAMPLE WAS TYPED AS BLOODGROUP A RH(D) NEGATIVE WITH ERYTYPE S ABD+REV.A1, B ON TANGO OPTIMO. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND THE RESULT CAME BACK AS BLOODGROUP AB RH(D) NEGATIVE. THE CUSTOMER FURTHER REPORTED THAT THE ANTI-A WELL IN ERYTYPE S ABD+REV.A1, B DID NOT HAVE ENOUGH RED BLOOD CELLS. THE RED BLOOD CELLS ARE PIPETTED OUT OF THE PATIENT RESPECTIVELY DONOR SAMPLES BY THE TANGO OPTIMO, WHEREAS THE ANTISERA LIKE ANTI-A AND ANTI-B ARE ALREADY DRIED IN THE READY FOR USE ERYTYPE S ABD+REV.A1, B MICROTEST PLATE. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF ERYTYPE S ABD+REV.A1, B WITH DIFFERENT RED BLOOD CELLS ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S ABD+REV.A1, B FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALIT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6459626 ↗
• MalfunctionMar 8, 2017Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED DISCREPANT TEST RESULTS BETWEEN THE TANGO OPTIMO AND TANGO INFINITY FOR RH(D) WHEN TESTING WITH ERYTYPE S ABD+REV.A1, B. A PATIENT SAMPLE YIELDED A 1+ POSITIVE RESULT WITH BOTH ANTI-D CLONES OF ERYTYPE S ABD+REV.A1,B ON TANGO INFINITY, BUT NEGATIVE RESULTS WITH BOTH ANTI-D CLONES OF ERYTYPE S ABD+REV.A1, B ON TANGO OPTIMO. THE CUSTOMER RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT FOR INVESTIGATIONAL TESTING, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE QC LAB'S RETAINED SAMPLE OF ERYTYPE S ABD+REV.A1, B ON TANGO OPTIMO. THE PATIENT SAMPLE YIELDED A NEGATIVE REACTION WITH BOTH ANTI-D REAGENTS ON ERYTYPE S ABD+REV.A1, B. AT VISUAL ASSESSMENT SOME VERY SMALL AGGLUTINATES WERE VISIBLE, INDICATING A VERY WEAK POSITIVE REACTION. THE SAMPLE WAS SENT FOR MOLECULAR RH(D) TYPING TO AN EXTERNAL LABORATORY. WE ARE STILL WAITING FOR THE RESULT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY OUR FIELD SERVICE ENGINEERS AND IS WORKING WITHIN SPECIFICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6386736 ↗
• MalfunctionFeb 28, 2017Incorrect Or Inadequate Test Results; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED DISCREPANT RESULTS OF ERYTYPE S ABD+REV.A1, B WHEN TESTED ON TANGO OPTIMO DUE TO ARTEFACTS IN REVERSE TYPING. THE CUSTOMER STATED TO SEND IN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR THE SUPPOSEDLY DEFECTIVE PRODUCT AND THE SAMPLES THAT HAD CAUSED THE FALSE POSITIVE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6363719 ↗