TANGO infinity 850000010Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 07611969961719), received between Aug 24, 2016 and Jun 4, 2025 — classified as 1 death, 54 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (29 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE (OR VERY WEAK REACTION) RH BLOOD TYPING RESULT WITH SAMPLE NO. (B)(6) ON THEIR TANGO INFINITY INSTRUMENT. ALL OTHER RESULTS, INCLUDING DAILY QC, WERE WITHIN EXPECTED RESULTS. THE SAMPLE ORIGINATED FROM A MATERNAL ADVANCE AGE WOMAN AND IS CONFIRMED BY A REFERENCE LAB AS A RHD POSITIVE AND NEGATIVE FOR ANTIBODY SCREENING. NO SAMPLE WAS LEFT TO BE PROVIDED FOR THE INVESTIGATION. THE INVESTIGATION OF THE AFFECTED TANGO INFINITY INSTRUMENT IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139640 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED VARIABLE FRONT TYPE RESULTS ON TANGO INFINITY. IN ONE CASE (SUBJECT TO THIS REPORT) A FALSE POSITIVE RESULTS IN THE NEGATIVE CONTROL WELL WHEN USING ERYTYPE S ABO CONFIRM AND ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. THE SAMPLE WAS TESTED ON (B)(6) 2025 AT 10:29:48 AND SHOWED A FALSE-POSITIVE RESULT IN THE NEGATIVE CONTROL WELL. THE SAME SAMPLE WAS RETESTED AT 10:58:51, AND THE RESULT RETURNED CORRECTLY AS EXPECTED (NEGATIVE CONTROL: NEGATIVE) BY TANGO INFINITY. THE CUSTOMER DID NOT PROVIDE SAMPLES OF THE AFFECTED PRODUCTS ERYTYPE S ABO CONFIRM AND ERYTYPE S ABD+REV.A1, B FOR INVESTIGATIONAL TESTING. THEREFORE, UR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES OF THE AFFECTED PRODUCTS ERYTYPE S ABO CONFIRM AND ERYTYPE S ABD+REV.A1, B. FIRST, THE PLATES WERE VISUALLY CHECKED AND SHOWED NO ABNORMALIES OR DETACHMENTS OF THE COATING. THEN THE COMPLAINED LOTS OF ERYTYPE S ABO CONFIRM AND ERYTYPE S ABD+REV.A1, B WERE TESTED WITH BROMELIN FOR ERYTYPE AND ERYTYPECELL A1, B ON THE QC LAB'S TANGO INFINITY. ONE BLOOD DONOR WITH BLOOD GROUP B WAS USED FOR THE POSITIVE SPECIFICITY AND 6 BLOOD DONORS WITH BLOOD GROUP A RHD POSITIVE WERE USED FOR NEGATIVE SPECIFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662182 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED VARIABLE FRONT TYPE RESULTS ON TANGO INFINITY. IN ONE CASE THE CUSTOMER YIELDED A FALSE POSITIVE RESULTS IN THE NEGATIVE CONTROL WELL WHEN USING ERYTYPE S ABO CONFIRM AND ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY (SEE REPORT 9610824-2025-08). IN A SECOND CASE, THE CUSTOMER REPORTED A FALSE-POSITIVE REACTION IN THE ANTI-B WELL WHEN USING ERYTYPE S ABO CONFIRM AND ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY (SUBJECT TO THIS REPORT). THIS SAMPLE WAS TESTED ON (B)(6) 2025 AT 07:48:43 AND SHOWED A FALSE-POSITIVE RESULT IN THE ANTI-B WELL. THE SAME SAMPLE WAS RETESTED AT 08:20:51, AND THE RESULT RETURNED CORRECTLY AS EXPECTED (ANTI-B: NEGATIVE). THE CUSTOMER DID NOT PROVIDE SAMPLES OF THE AFFECTED PRODUCTS ERYTYPE S ABO CONFIRM AND ERYTYPE S ABD+REV.A1, B FOR INVESTIGATIONAL TESTING. THEREFORE, UR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES OF THE AFFECTED PRODUCTS ERYTYPE S ABO CONFIRM AND ERYTYPE S ABD+REV.A1, B. FIRST, THE PLATES WERE VISUALLY CHECKED AND SHOWED NO ABNORMALIES OR DETACHMENTS OF THE COATING. THEN THE COMPLAINED LOTS OF ERYTYPE S ABO CONFIRM AND ERYTYPE S ABD+REV.A1, B WERE TESTED WITH BROMELIN FOR ERYTYPE AND ERYTYPECELL A1, B ON THE Q

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662181 ↗
• MalfunctionJan 30, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE TEST RESULTS OF A RH NEGATIVE PATIENT SAMPLE WHEN TESTED ON TANGO OPTIMO. THE CUSTOMER PERFORMED THE BLOOD TYPING OF THE SAMPLE ON THE INSTRUMENT AND YIELDED A 1+ REACTION ON RH CONFIRMATION. THE CUSTOMER REPEATED WITH NEW SEGMENT OF THE BLOOD UNIT AND THEY GOT A 1+ REACTION AGAIN. THE CUSTOMER REPEATED THE TEST WITH NEW PLATES, GOT 1+ AGAIN. AFTER RUNNING THE MONTHLY MAINTENANCE, THE TEST WAS REPEATED AND SHOWED 1+ AGAIN. BENCH TESTING (WITH TUBE METHOD) YIELDED A NEGATIVE RESULT, AND THE WEAK D WAS NEGATIVE AS WELL. AFTER CHANGING THE BROMELIN, THE CUSTOMER WAS ABLE TO GET A NEGATIVE REACTION. ALL QC TESTS RESULTS WERE AS EXPECTED AND OTHER PATIENT'S RESULTS WERE ALL CONSISTENT. THE INVESTIGATION IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272920 ↗
• MalfunctionMar 21, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF SOLIDSCREEN II CONTROL B WITH BIOTESTCELL 3 ON TANGO INFINITY. SOLIDSCREEN II CONTROL B CONTAINS AN ANTI-C THAT IS DESIGNED TO REACT POSITIVELY WITH CELLS NO. 2 AND NO. 3 OF BIOTESTCELL 3. THE CUSTOMER PROVIDED A SNAPSHOT OF TANGO INFINITY THAT SHOWED ONE NEGATIVE REACTION OF THE CONTROL WITH ALL THREE SCREENING CELLS OF BIOTESTCELL 3. THE CUSTOMER DID NOT RETURN A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH BIOTESTCELL 3 ON TANGO INFINITY. CELL NO.2 AND NO.3 OF BIOTESTCELL 3 SHOWED CORRECTLY POSITIVE RESULTS.A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. LOGFILES OF THE AFFECTED TANGO INFINITY INSTRUMENT WERE ANALYZED. THE AFFECTED CONTROL HAS THE BARCODE LABEL C504000044 AND WAS PROCESSED ON 2024-03-02. ON THE SAME STRIP AS THE AFFECTED CONTROL SAMPLE ANOTHER CONTROL WAS PROCESSED, NO. C507000069, THIS SECOND CONTROL RESULTED IN TWO POSITIVE WELLS, WHICH SHOWS THAT THE AHG WAS STILL WORKING AT THIS TIME.CHECKING THE RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950225 ↗
• MalfunctionOct 2, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF POSITIVE CONTROLS WITH ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLID SCREEN II ON ONE OF THEIR TANGO INFINITY INSTRUMENTS. THE SAME CONTROL PASSED ON THEIR OTHER TANGO INFINITY INSTRUMENT. THE CUSTOMER STATED THAT THE ANTIBODY SCREENING TEST WITH BIOTEST CELL 1&2 AND THE WEAK TESTING WITH SOLID SCREEN II ANTI-D BLEND WERE AFFECTED. THE CUSTOMER PROVIDED TANGO INFINITY SCREENSHOTS WHICH SHOWED NEGATIVE REACTIONS WITH BIOTESTCELL 1&2 AND SOLIDSCREEN II ANTI-D BLEND. THE SCREENSHOTS ALSO SHOWED THAT THE NEGATIVE RESULTS WERE FLAGGED, EITHER AS "CONTROL FAILED" OR AS "DISCREPANT RESULT". THE CUSTOMER NEITHER PROVIDED A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE CONTROLS WHICH SHOWED FALSE NEGATIVES. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT, CONTROLS, KNOWN ANTIBODIES AND BIOTESTCELL 1&2 ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY, THE RETENTION SAMPLE OF THE AHG ANTI-IGG SOLIDSCREEN II WAS TESTED FOR POTENCY AND MET THE ACCEPTANCE CRITERION. A REVIEW OF THE BATCH RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852296 ↗
• MalfunctionOct 2, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF POSITIVE CONTROLS WITH ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II ON ONE OF THEIR TANGO INFINITY INSTRUMENTS. THE SAME CONTROL PASSED ON THEIR OTHER TANGO INFINITY INSTRUMENT. THE CUSTOMER STATED THAT THE ANTIBODY SCREENING TEST WITH BIOTESTCELL 1&2 AND THE WEAK D TESTING WITH SOLIDSCREEN II ANTI-D BLEND WERE AFFECTED. A SAMPLE OF THE AFFECTED PRODUCT WAS REQUESTED FROM THE CUSTOMER AS WELL AS FURTHER INFORMATION. OUR QUALITY CONTROL LABORATORY HAS NOT YET STARTED TESTING THEIR RETENTION SAMPLE OF THE AFFECTED PRODUCT BUT IS WAITING FOR THE COMPLAINT MATERIAL THE CUSTOMER ANNOUNCED TO SEND IN FOR INVESTIGATIONAL TESTING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. INSTRUMENT DATA AND LOG FILES OF THE AFFECTED TANGO INFINITY HAVE BEEN REQUESTED AND RECEIVED. OUR TECHNICAL SUPPORT IS STIL WAITING FOR SOME REQUESTED INFORMATION IN ORDER TO BE ABLE TO ANALYZE THE INSTRUMENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849949 ↗
• MalfunctionMar 22, 2023Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER REPORTED AN ISSUE CONCERNING THE TANGO INFINITY: THE SYSTEM LIQUID CONTAINER INTERMITTENTLY LOST ITS CONNECTION. APPARENTLY, THE SENSOR CABLE DID BREAK APART ON THE SYSTEM LIQUID CONTAINER CAUSING INTERMITTENT LEVEL SENSING ISSUES. A NEW USER DID NOT DISCONNECT THE CONTAINERS CORRECTLY AND THUS THE WIRING WAS EXPOSED ON THE CONNECTORS DUE TO THE PULLING. THE CUSTOMER CLAINED TO HAVE RECEIVED A VERY LIGHT ELECTRICAL SHOCK AS SHE WAS RECONNECTING THE CONTAINER. SHE CONFIRMED THAT NO MEDICAL TREATMENT WAS REQUIRED, NO MARKS, NO OTHER HARM. BESIDE THE POWER SUPPLY AND THE MAIN SWITCH, THERE IS NO HIGH VOLTAGE USED IN THE TANGO INFINITY SYSTEM, THE OPERATING VOLTAGE IS 24 V. THE TANGO INFINITY WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS. REGARDING THE BROKEN ELECTRICAL CONNECTION ON THE SYSTEM LIQUID CONTAINER, HE DISCONNECTED THE SYSTEM LIQUID LEVEL SENSING WIRE. THE FIELD SERVICE ENGINEER (FSE) ENSURED THAT NO HIGH OR UNUSUAL VOLTAGE WAS COMING FROM THE INSTRUMENT'S SYSTEM LIQUID LEVEL SENSING LINE. ADDITIONALLY, THE FSE ENSURED NO VOLTAGE WAS COMING FROM THE DISCONNECTED SYSTEM LIQUID CONTAINER, AND ENSURED NO ELECTRICAL WIRES ARE EXPOSED. HE FOUND NO HINT FOR A

  Patient problems: Electric Shock

  MAUDE report 16589735 ↗
• MalfunctionJan 3, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FORWARD AND REVERSE GROUPING MISMATCHES ON TANGO INFINITY. THE CUSTOMER STATED THAT THEY OBSERVED FALSE POSITIVE REACTIONS IN THE ANTI-B WELL OF ERYTYPE S ABD+REV. A1, B ON TANGO INFINITY. THE CUSTOMER DID NOT RETURN A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT ERYTYPE S ABD+REV. A1, B FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV. A1, B WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. IN OUR TESTING, WE HAD FOCUSED ON BLOOD GROUP A SAMPLES SINCE SAMPLES OF THIS BLOOD GROUP SHOWED THE FALSE POSITIVE RESULTS IN ANTI-B ON TANGO INFINITY AT THE CUSTOMER. ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESULT WITH ANTI-B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.. THE DATA OF THE AFFECTED TANGO INFINITY WERE ANALYZED AND THE FOLLOWING PATTERN WAS FOUND: A POSITIVE ANTI-A FOLLOWED BY A FALSE POSITIVE RESULT IN THE ANTI-B WELL. THIS IS MOST PROBABLE CAUSED BY A CARRYOVER FROM THE POSITIVE ANTI-

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085776 ↗
• MalfunctionJan 3, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FORWARD AND REVERSE GROUPING MISMATCHES ON TANGO INFINITY. THE CUSTOMER STATED THAT THEY OBSERVED FALSE POSITIVE REACTIONS IN THE ANTI-B WELL OF ERYTYPE S ABD+REV. A1, B ON TANGO INFINITY. THE CUSTOMER DID NOT RETURN A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT ERYTYPE S ABD+REV.A1,B FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULT. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1,B WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. IN OUR TESTING, WE FOCUSED ON BLOOD GROUP A SAMPLES, SINCE SAMPLES OF THIS BLOOD GROUP SHOWED THE FALSE POSITIVE RESULTS IN ANTI-B ON TANGO INFINITY AT THE CUSTOMER. ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESULT WITH ANTI-B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE CUSTOMER REPORTED THIS ISSUE INITIALLY ON (B)(6) 2022. OUR INVESTIGATIN SHOWED FALSE POSITIVE RESULTS WERE ALSO OBTAINED ON (B)(6) 2022. IN THIS REPORT, WE STILL STATED (B)(6) 2022 AS THE DATE WE BECAME AWARE OF THESE TWO INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085775 ↗
• MalfunctionJan 3, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FORWARD AND REVERSE GROUPING MISMATCHES ON TANGO INFINITY. THE CUSTOMER STATED THAT THEY OBSERVED FALSE POSITIVE REACTIONS IN THE ANTI-B WELL OF ERYTYPE S ABD+REV. A1, B ON TANGO INFINITY. THE CUSTOMER DID NOT RETURN A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT ERYTYPE S ABD+REV. A1, B FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV. A1, B WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. IN OUR TESTING, WE HAD FOCUSED ON BLOOD GROUP A SAMPLES SINCE SAMPLES OF THIS BLOOD GROUP SHOWED THE FALSE POSITIVE RESULTS IN ANTI-B ON TANGO INFINITY AT THE CUSTOMER. ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESULT WITH ANTI-B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.. THE DATA OF THE AFFECTED TANGO INFINITY WERE ANALYZED AND THE FOLLOWING PATTERN WAS FOUND: A POSITIVE ANTI-A FOLLOWED BY A FALSE POSITIVE RESULT IN THE ANTI-B WELL. THIS IS MOST PROBABLE CAUSED BY A CARRYOVER FROM THE POSITIVE ANTI-

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085774 ↗
• MalfunctionFeb 7, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF PATIENT SAMPLES WITH BOTH ANTI-D REAGENTS OF ERYTYPE S ABD+REV.A1, B WHEN USED ON TANGO INFINITY. THE CUSTOMER STATED THAT THE PATIENT IS HISTORICALLY RHD POSITIVE. THE CUSTOMER ANNOUNCED TO SEND IN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR IT. . 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 FILED A COMPLAINT REGARDING THE SAME ISSUE (SAME INSTRUMENT BUT DIFFERENT LOT OF ERYTYPE S ABD+REV. A1, B) ON (B)(6) 2021. THIS COMPLAINT WAS FILED AS COMPLAINT (B)(4) AND REPORTED TO FDA UNDER NO. 9610824-2021-00077 AND 9610824-2021-00084. FOR THIS NEW COMPLAINT, THE CUSTOMER PROVIDED RESULT IMAGES. THE LAST PREVENTIVE MAINTENANCE ON THE INSTRUMENT WAS CONDUCTED ON (B)(6) 2021. THE LOG FILES OF THE AFFECTED INSTRUMENTS WERE ANALYZED. THIS ANALYSIS SHOWED THAT THE FALSE NEGATIVE ANTI-D DETECTION IS A CAUSED BY A WRONG STRIP USED FOR THE SAMPLE PROCESSING. IN THE REPORTED CASES, A SOLIDSCREEN II STRIP WAS USED INSTEAD OF AN ABDREVA1B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470169 ↗
• MalfunctionFeb 7, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF PATIENT SAMPLES WITH BOTH ANTI-D REAGENTS OF ERYTYPE S ABD+REV.A1, B WHEN USED ON TANGO INFINITY. THE CUSTOMER STATED THAT THE PATIENT IS HISTORICALLY RHD POSITIVE. THE CUSTOMER ANNOUNCED TO SEND IN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR IT. 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 FILED A COMPLAINT REGARDING THE SAME ISSUE (SAME INSTRUMENT BUT DIFFERENT LOT OF ERYTYPE S ABD+REV. A1, B) ON (B)(6) 2021. THIS COMPLAINT WAS FILED AS COMPLAINT (B)(4) AND REPORTED TO FDA UNDER NO. 9610824-2021-00077 AND 9610824-2021-00084. FOR THIS NEW COMPLAINT, THE CUSTOMER PROVIDED RESULT IMAGES. THE LAST PREVENTIVE MAINTENANCE ON THE INSTRUMENT WAS CONDUCTED ON (B)(6) 2021. THE LOG FILES OF THE AFFECTED INSTRUMENTS WERE ANALYZED. THIS ANALYSIS SHOWED THAT THE FALSE NEGATIVE ANTI-D DETECTION IS A CAUSED BY A WRONG STRIP USED FOR THE SAMPLE PROCESSING. IN THE REPORTED CASES, A SOLIDSCREEN II STRIP WAS USED INSTEAD OF AN ABDREVA1B ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470167 ↗
• MalfunctionFeb 7, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF PATIENT SAMPLES WITH BOTH ANTI-D REAGENTS OF ERYTYPE S ABD+REV.A1, B WHEN USED ON TANGO INFINITY. THE CUSTOMER STATED THAT THE PATIENT IS HISTORICALLY RHD POSITIVE. THE CUSTOMER ANNOUNCED TO SEND IN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR IT. . 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 FILED A COMPLAINT REGARDING THE SAME ISSUE (SAME INSTRUMENT BUT DIFFERENT LOT OF ERYTYPE S ABD+REV. A1, B) ON NOVEMBER 01, 2021. THIS COMPLAINT WAS FILED AS COMPLAINT (B)(4) AND REPORTED TO FDA UNDER NO. 9610824-2021-00077 AND 9610824-2021-00084. FOR THIS NEW COMPLAINT, THE CUSTOMER PROVIDED RESULT IMAGES. THE LAST PREVENTIVE MAINTENANCE ON THE INSTRUMENT WAS CONDUCTED ON NOVEMBER 15,2021. THE LOG FILES OF THE AFFECTED INSTRUMENTS WERE ANALYZED. THIS ANALYZIS SHOWED THAT THE FALSE NEGATIVE ANTI-D DETECTION IS A CAUSED BY A WRONG STRIP USED FOR THE SAMPLE PROCESSING. IN THE REPORTED CASES, A SOLIDSCREEN II STRIP WAS USED INSTEAD OF AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470165 ↗
• MalfunctionFeb 7, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF PATIENT SAMPLES WITH BOTH ANTI-D REAGENTS OF ERYTYPE S ABD+REV.A1, B WHEN USED ON TANGO INFINITY. THE CUSTOMER STATED THAT THE PATIENT IS HISTORICALLY RHD POSITIVE. THE CUSTOMER ANNOUNCED TO SEND IN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR IT. . 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 FILED A COMPLAINT REGARDING THE SAME ISSUE (SAME INSTRUMENT BUT DIFFERENT LOT OF ERYTYPE S ABD+REV. A1, B) ON (B)(6) 2021. THIS COMPLAINT WAS FILED AS COMPLAINT (B)(4) AND REPORTED TO FDA UNDER NO. 9610824-2021-00077 AND 9610824-2021-00084. FOR THIS NEW COMPLAINT, THE CUSTOMER PROVIDED RESULT IMAGES. THE LAST PREVENTIVE MAINTENANCE ON THE INSTRUMENT WAS CONDUCTED ON (B)(6) 2021. THE LOG FILES OF THE AFFECTED INSTRUMENTS WERE ANALYZED. THIS ANALYZIS SHOWED THAT THE FALSE NEGATIVE ANTI-D DETECTION IS A CAUSED BY A WRONG STRIP USED FOR THE SAMPLE PROCESSING. IN THE REPORTED CASES, A SOLIDSCREEN II STRIP WAS USED INSTEAD OF AN ABDREVA1B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470162 ↗
• MalfunctionMar 25, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT TWICE YIELDED FALSE NEGATIVE RH(D) RESULTS ON TANGO INFINITY WHEN USING ERYTYPE S ABD+REV.A1, B. THE CUSTOMER STATED THAT TWO DIFFERENT SAMPLES OF THE PATIENT WERE TESTED ON TANGO INFINITY AND SHOWED THE FALSE NEGATIVE RESULTS. THE PATIENT HAD BEEN TESTED RH(D) POSITIVE ON TANGO OPTIMO IN 2020. THE RH(D) POSITIVE RESULT WAS NOW CONFIRMED BY ANOTHER LABORATORY. THE CUSTOMER DID NOT SEND IN A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT ERYTYPE S ABD+REV.A1, B FOR INVESTIGATIONAL TESTING NOR A PATIENT SAMPLE. 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. 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 A BLACK/WHITE RESULT IMAGE OF POOR QUALITY THAT SHOWS A NEGATIVE REACTION FOR BOTH ANTI-D WELLS. THE LAST PREVENTATIVE MAINTENANCE WAS CONDUCTED ON MARCH 17, 2021 AND THE SERVICE ENGINEER CONFIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568147 ↗
• MalfunctionMar 25, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT TWICE YIELDED FALSE NEGATIVE RH(D) RESULTS ON TANGO INFINITY WHEN USING ERYTYPE S ABD+REV.A1, B. THE CUSTOMER STATED THAT TWO DIFFERENT SAMPLES OF THE PATIENT WERE TESTED ON TANGO INFINITY AND SHOWED THE FALSE NEGATIVE RESULTS. THE PATIENT HAD BEEN TESTED RH(D) POSITIVE ON TANGO OPTIMO IN 2020. THE RH(D) POSITIVE RESULT WAS NOW CONFIRMED BY ANOTHER LABORATORY. THE CUSTOMER DID NOT SEND IN A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT ERYTYPE S ABD+REV.A1, B FOR INVESTIGATIONAL TESTING NOR A PATIENT SAMPLE. 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. 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 A BLACK/WHITE RESULT IMAGE OF POOR QUALITY THAT SHOWS A NEGATIVE REACTION FOR BOTH ANTI-D WELLS. THE LAST PREVENTATIVE MAINTENANCE WAS CONDUCTED ON MARCH 17, 2021 AND THE SERVICE ENGINEER CONFIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568145 ↗
• MalfunctionFeb 3, 2020False Positive Result; Defective Device

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS IN THE ANTI-B WELLS OF ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT SAMPLES OF THE BLOOD GROUP A WERE AFFECTED. THE CUSTOMER HAS NEITHER RETURNED THE SAMPLE THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS NOR THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. WE REQUESTED AND ARE STILL AWAITING FURTHER INFORMATION, E.G. THE LOT NUMBER OF THE SUPPOSEDLY DEFECTIVE PRODUCT. DUE TO THE MISSING LOT INFORMATION A TESTING OF THE RETENTION SAMPLE AND THE REVIEW OF THE BATCH RECORD REVIEW DOCUMENTATION WAS SO FAR NOT POSSIBLE. REGARDING THE AFFECTED TANGO INFINITY: THE CUSTOMER PROVIDED RESULT IMAGES THAT SHOW THE DESCRIBED PHENOMENON: THE CELLS IN THE ANTI-B WELL WERE NOT COMPLETELY RESUSPENDED AND THERE WERE SPREAD DARK RED DOTS, WHICH LEAD THE INSTRUMENTS IMAGE EVALUATION SOFTWARE TO CALCULATE A POSITIVE RESULT. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TESTING, THE INSTRUMENT DID NOT GIVE OUT AN OVERALL BLOOD TYPE RESULT AND THUS NO FALSE RESULT WAS RELEASED. A FIELD SERVICE ENGINEER (FSE) WAS SEVERAL TIMES ON-SITE. SPOLV AND ORBITAL SHAKER WERE REPLACED AND THE LINEAR SHAKER LOADER ALIGNED, BUT THE PR

  Patient problems: Test Result

  MAUDE report 9659048 ↗
• MalfunctionFeb 3, 2020False Positive Result; Component Missing; Defective Device

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS IN THE ANTI-B WELLS OF ERYTYPE S ABD+REV.A1, B WHEN USED ON TANGO INFINITY. THE CUSTOMER STATED THAT SAMPLES OF THE BLOOD GROUP A WERE AFFECTED. THE CUSTOMER STATED THAT SHE FIRST OBSERVED THE ISSUE WITH HER QUALITY CONTROL (QC). THE LAB INTERNAL QC3 SHOULD BE BLOOD GROUP A RHD NEGATIVE, BUT SHE RECEIVED THE RESULT BLOOD GROUP AB. THE CUSTOMER RETESTED THE SAME REAGENTS ON ANOTHER TANGO INFINITY AND RECEIVED CORRECT RESULTS. FURTHERMORE THE CUSTOMER STATED THAT PATIENT SAMPLES WERE ALSO AFFECTED. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE CONTROL RESPECTIVELY PATIENT SAMPLES THAT CAUSED FALSE POSITIVE TEST RESULTS. BUT THE CUSTOMER PROVIDED TANGO INFINITY IMAGES WHICH DEMONSTRATED THE DESCRIBED ISSUE. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TESTING, THE INSTRUMENT DID NOT GIVE OUT AN OVERALL BLOOD TYPE RESULT AND THUS NO FALSE RESULT WAS RELEASED. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV. A1, B WITH DIFFERENT DONOR SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION.

  Patient problems: Reaction

  MAUDE report 9659046 ↗
• MalfunctionFeb 14, 2019False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE OR WEAK ANTIBODY SCREENING AND IDENTIFICATION RESULTS FOR SEVERAL SAMPLES WHEN COMPARED WITH RESULTS GENERATED WITH TUBE TESTING USING THE ENHANCEMENT MEDIUM POLYETHYLEN GLYCOL (PEG) AND THE COMPETITOR INSTRUMENT ECHO. IN PARTICULAR THE CUSTOMER REPORTED A MISSED ANTIBODY WHEN USING BIOTESTCELL 3 LOT #8850011-00 ON TWO DIFFERENT TANGO INFINITY INSTRUMENTS. THE CUSTOMER STATED THAT THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-JK(A). DURING THE COURSE OF COMPLAINT HANDLING THE CUSTOMER INFORMED US ABOUT THE FALSE NEGATIVE REACTION OF THE ANTI-JK(A) WITH BIOTESTCELL-I11 (REF # 816021100, LOT #8849011-00, EXPIRY DATE 2019-01-28). AT THE TIME THE CUSTOMER INFORMED US ABOUT THE SUPPOSEDLY DEFECTIVE PRODUCT, THE LOT OF BIOTESTCELL-I1 WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY DID NOT TEST THEIR RETENTION SAMPLE. THE CUSTOMER DID NOT RETURN THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT BUT THE COMPLAINT SAMPLE BIOTESTCELL 3, THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLID SCREEN II AND MLB2. AT THE TIME OUR QUALITY CONTROL LABORATORY RECEIVED THE REAGENTS PROVIDED BY THE CUSTOMER , THE SUPPOSEDLY DEFECTIVE LOT OF BIO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8338641 ↗
• MalfunctionFeb 14, 2019False Negative Result; Component Missing; Defective Device

  THE CUSTOMER REPORTED FALSE NEGATIVE OR WEAK ANTIBODY SCREENING AND IDENTIFICATION RESULTS FOR SEVERAL SAMPLES WHEN COMPARED WITH RESULTS GENERATED WITH TUBE TESTING USING THE ENHANCEMENT MEDIUM POLYETHYLEN GLYCOL (PEG) AND THE COMPETITOR INSTRUMENT ECHO. IN PARTICULAR THE CUSTOMER REPORTED A MISSED ANTIBODY WHEN USING BIOTESTCELL 3 LOT #8850011-00 ON TWO DIFFERENT TANGO INFINITY INSTRUMENTS. THE CUSTOMER STATED THAT THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-JK(A). DURING THE COURSE OF THE COMPLAINT HANDLING THE CUSTOMER INFORMED US ABOUT THE FALSE NEGATIVE REACTION OF THE ANTI-JK(A) WITH BIOTESTCELL-I11 PLUS (REF # 816022100, LOT #8850011-00, EXPIRY DATE 2019-02-04. AT THE TIME THE CUSTOMER INFORMED US, THE SUPPOSEDLY DEFECTIVE LOT OF BIOTESTCELL-I11 PLUS WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY DID NOT TEST THEIR RETENTION SAMPLE. THE CUSTOMER DID NOT RETURN THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT BUT THE COMPLAINT SAMPLE, TWO DIFFERENT LOTS OF ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II AND MLB2. AT THE TIME OUR QUALITY CONTROL LABORATORY RECEIVED THE REAGENTS PROVIDED BY THE CUSTOMER, THE SUPPOSEDLY DEFECTIVE LOT OF BIOTE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8338640 ↗
• MalfunctionDec 14, 2018False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESPECTIVELY WEAKER ANTIBODY SCREENING RESULTS WITH BIOTESTCELL 3 ON TANGO INFINITY. THE CUSTOMER STATED THAT THEY WERE RUNNING A CORRELATION STUDY WITH TANGO INFINITY, AN INSTRUMENT OF A COMPETITOR (ECHO) AND IN THE MANUAL TUBE METHOD WITH AN ENHANCEMENT MEDIUM. HE STATED THAT IN FOUR CASES, THE REACTIONS ON TANGO INFINITY WERE FALSE NEGATIVE RESPECTIVELY WEAKER POSITIVE THAN EXPECTED. THE SPECIFICITY OF THE AFFECTED ANTIBODIES WAS ANTI-FY(A), ANTI-K AND TWICE AN ANTI-JK(A). THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SPECIMENS THAT CAUSED FALSE NEGATIVE TEST RESULTS. AT THE TIME THE CUSTOMER FILED HIS COMPLAINT, THE SUPPOSEDLY DEFECTIVE LOT BIOTESTCELL 3 WAS ALREADY EXPIRED. THEREFORE THE RETENTION SAMPLE COULD NOT BE TESTED IN OUR QUALITY CONTROL LABORATORY. DUE TO THE FACT THAT THE SUPPOSEDLY DEFECTIVE PRODUCT WAS EXPIRED AND NO PATIENT SAMPLES ARE AVAILABLE, AN INVESTIGATION COULD NOT BE CARRIED OUT. 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, T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8163493 ↗
• MalfunctionDec 14, 2018False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESPECTIVELY WEAKER ANTIBODY SCREENING RESULTS WITH BIOTESTCELL 3 ON TANGO INFINITY. THE CUSTOMER STATED THAT THEY WERE RUNNING A CORRELATION STUDY WITH TANGO INFINITY, AN INSTRUMENT OF A COMPETITOR (ECHO) AND IN THE MANUAL TUBE METHOD WITH AN ENHANCEMENT MEDIUM. HE STATED THAT IN FOUR CASES, THE REACTIONS ON TANGO INFINITY WERE FALSE NEGATIVE RESPECTIVELY WEAKER POSITIVE THAN EXPECTED. THE SPECIFICITY OF THE AFFECTED ANTIBODIES WAS ANTI-FY(A), ANTI-K AND TWICE AN ANTI-JK(A). THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SPECIMENS THAT CAUSED FALSE NEGATIVE TEST RESULTS. AT THE TIME THE CUSTOMER FILED HIS COMPLAINT, THE SUPPOSEDLY DEFECTIVE LOT BIOTESTCELL 3 WAS ALREADY EXPIRED. THEREFORE THE RETENTION SAMPLE COULD NOT BE TESTED IN OUR QUALITY CONTROL LABORATORY. DUE TO THE FACT THAT THE SUPPOSEDLY DEFECTIVE PRODUCT WAS EXPIRED AND NO PATIENT SAMPLES ARE AVAILABLE, AN INVESTIGATION COULD NOT BE CARRIED OUT. 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, T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8163492 ↗
• MalfunctionNov 30, 2018Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ABOUT MIXED FIELD REACTION NOT PICKED UP BY THE INSTRUMENT WHEN TESTING WITH ERYTYPE S ABD+REV. A1,B ON TANGO INFINITY. SUMMARY: BASED ON BLOOD TYPING RESULT FROM OCT 23, WHICH TURNED LATER OUT TO BE FROM WRONG PATIENT, THE CONCERNED PATIENT (WHO IS TRUE TYPE A RH D POS.) WAS GIVEN 4 UNITS OF O RH D POSITIVE BLOOD OVER THE NEXT 3 DAYS. ON OCT 24TH, PATIENT HAD BEEN ADDITIONALLY TRANSFUSED WITH ONE UNIT OF B POS PLASMA. ON OCT 27, A SAMPLE WAS DRAWN FROM THIS TRANSFUSED PATIENT AND TESTED ON TANGO INFINITY SN (B)(4). THE RESULT WAS O RH D POS. BUT THE CUSTOMER AWAITED A MIXED FIELD RESULT INTERPRETATION BY INSTRUMENT'S EVALUATION SOFTWARE DUE TO THE PREVIOUS TRANSFUSION. THE CUSTOMER PERFORMED TESTING WITH REFERENCE METHODS BY TUBE AND GEL AND COULD OBSERVE MIXED FIELD REACTIONS THERE. ANOTHER SAMPLE WAS DRAWN ON OCT 31 AND TESTED ON THE SAME TANGO INFINITY. THE RESULT WAS EVALUATED BY INSTRUMENT AS A RH D POSITIVE THIS TIME. THE RESULT IMAGES PROVIDED BY THE CUSTOMER WERE EVALUATED. VISUALLY, THE MIXED FIELD REACTION IN THE FRONT TYPE CAN BE MARGINALLY OBSERVED, BUT THERE ARE NOT ENOUGH PIXELS TO INTERPRET THE RESULT AS POSITIVE BY INSTRUMENTS RESULT EVALUATIO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8118912 ↗
• MalfunctionNov 22, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED ABOUT DISCREPANCY IN BLOOD GROUP TYPING BETWEEN TANGO INFINITY RESULT SCREEN (O RH D NEGATIVE) AND RESULT AFTER TRANSMISSION TO THE LABORATORY INFORMATION SYSTEM (LIS) ON THE LIS SCREEN (B RH D NEGATIVE). HE STATED THAT THE TANGO INFINITY SENT A SAMPLE TO THE LIS, THE INFINITY HAD THE CORRECT RESULT BUT THE LIS SHOWED A DIFFERENT RESULT. THE CUSTOMER PROVIDED THE RESULT IMAGES GENERATED BY THE TANGO INFINITY AS WELL AS BY THE LIS. AS ALREADY MENTIONED, THE TANGO INFINITY RESULT WAS AN O RH D NEGATIVE, BUT AFTER TRANSMISSION TO CUSTOMERS LIS, IT SHOWED AS B RH D NEGATIVE ON LIS SIDE. AN ANALYSIS OF THE ASTM LOG SHOWS INCORRECT BEHAVIOR OF THE CUSTOMER'S LIS SYSTEM. THE RESULT WAS CORRECTLY GENERATED BY AND TRANSMITTED FROM THE TANGO INFINITY: THE TANGO INFINITY'S ASTM LOG FILE WAS REVIEWED. IT WAS CONFIRMED THAT THE RESULTS FROM TANGO WERE O NEG FOR SAMPLE ID 1936604. IT WAS CONFIRMED THAT THE RESULT WAS TRANSMITTED CORRECTLY FROM THE TANGO INFINITY TO THE LIS. IT WAS DISCOVERED THAT THE LIS APPEARED TO HAVE BEEN ATTEMPTING TO TRANSMIT TEST ORDER REQUESTS TO THE TANGO WHILE THE TANGO WAS SENDING RESULTS. THIS RESULTED IN THE TANGO INFINITY TO SEND THE SAME LINE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8098726 ↗