Erytypecell® A1 & B 816056100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07611969952656), received between Nov 7, 2017 and Mar 18, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF ONE PATIENT SAMPLE WITH ERYTYPECELL B WHEN USED ON TWO INSTRUMENTS, THE TANGO INFINITY AND THE TANGO OPTIMO. BECAUSE NEITHER THE COMPLAINT SAMPLE NOR THE PATIENT SAMPLE WERE AVAILABLE FOR INVESTIGATION,OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLE ON BOTH INSTRUMENTS. THE TESTING WAS DONE IN PARALLEL WITH A REFERENCE LOT OF ERYTYPECELL A1&B (LOT #9106011-00). ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESULT. . A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. IMAGES OF THE INCIDENT HAVE SO FAR NOT BEEN PROVIDED. SINCE THE SAME RESULTS WERE OBSERVED ON BOTH, THE TANGO INFINITY AND THE TANGO OPTIMO, AN INSTRUMENT ISSUE IS MOST LIKELY NOT THE CAUSE. FURTHER INVESTIGATIONS ARE NOT POSSIBLE WITHOUT FURTHER INFORMATION. WE ARE WAITING FOR ADDITIONAL INFORMATION, IMAGES AND LOG FILES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516852 ↗
• MalfunctionAug 7, 2019Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ISSUES WHEN TESTING WITH ERYTYPECELL A1&B ON TANGO OPTIMO. THE CUSTOMER STATED THAT SHE OBSERVED DEBRIS AND JUNK IN THE REVERSE TYPING WHICH CAUSED FALSE POSITIVE RESULTS. THE CUSTOMER PROVIDED IMAGES OF THE TANGO OPTIMO; THESE IMAGES SHOW REACTIONS WHICH WERE SUPPOSED TO BE NEGATIVE. BUT DUE TO INSUFFICIENTLY RESUSPENDED RED BLOOD CELL SUSPENSIONS THERE IS A BUTTON OF RED BLOOD CELLS ON THE BOTTOM OF THE WELL WHICH IS ASSESSED AS A POSITIVE REACTION BY THE TANGO INSTRUMENT. AND AS SHOWN IN ONE PICTURE ONE FALSE NEGATIVE REACTION WITH ERYTYPECELL B OCCURRED. WE ARE WAITING FOR THE MATERIAL RETURNED BY THE CUSTOMER FOR INVESTIGATIONAL TESTING. IN THE MEANTIME OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPECELL A1&B WITH DIFFERENT SAMPLES ON ERYTYPE S ABD+REV.A1, B ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESPECTIVELY FALSE NEGATIVE REACTION. AND ALL NEGATIVE REACTIONS WERE COMPLETELY RE-SUSPENDED. USUALLY, INSUFFICIENTLY RESUSPENDED RED BLOOD CELL SUSPENSIONS CAN EASILY BE DIFFERENTIATED FROM REAL POSITIVE REACTIONS BY A VISUAL ASSESSMENT. A REVIEW OF THE BATCH RECORD DOCUME

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8868759 ↗
• MalfunctionAug 7, 2019Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ISSUES WHEN TESTING WITH ERYTYPECELL A1&B ON TANGO OPTIMO. THE CUSTOMER STATED THAT SHE OBSERVED DEBRIS AND JUNK IN THE REVERSE TYPING WHICH CAUSE FALSE POSITIVE TEST RESULTS. THE CUSTOMER PROVIDED IMAGES OF THE TANGO OPTIMO. THESE IMAGES SHOW REACTIONS WHICH WERE SUPPOSED TO BE NEGATIVE, BUT DUE TO INSUFFICIENTLY RESUSPENDED RED CELL SUSPENSIONS BUTTONS OF RED BLOOD CELLS REMAINED ON THE BOTTOM OF THE WELLS. THESE CELL BUTTONS WERE ASSESSED AS POSITIVE REACTIONS BY THE TANGO INSTRUMENT. AND AS SHOWN IN ONE PICTURE ONE FALSE NEGATIVE REACTION WITH ERYTYPECELL B OCCURRED. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT ERYTYPECELL A1&B FOR INVESTIGATIONAL TESTING BUT 42 ERYTYPE S ABD+ REV. A1, B PLATES. AT THE TIME WE RECEIVED THE ERYTYPE PLATES THE SUPPOSEDLY DEFECTIVE PRODUCT ERYTYPECELL A1&B WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED 10 OUT OF THE 42 ERYTYPE S ABD+REV. A1, B PLATES WITH THE CURRENT LOT OF ERYTYPECELL A1&B (LOT 8931011-00) ON THE TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS OR INSUFFICIENTLY RESUSPENDED NEGATIVE REACTIONS. WITHIN THE SHEL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8868755 ↗
• MalfunctionAug 7, 2019False Positive Result

  THE CUSTOMER REPORTED ISSUES WHEN TESTING WITH ERYTYPECELL A1&B ON TANGO OPTIMO. THE CUSTOMER STATED THAT SHE OBSERVED DEBRIS AND JUNK IN THE REVERSE TYPING WHICH CAUSE FALSE POSITIVE TEST RESULTS. THE CUSTOMER PROVIDED IMAGES OF THE TANGO OPTIMO. THESE IMAGES SHOW REACTIONS WHICH WERE SUPPOSED TO BE NEGATIVE, BUT DUE TO INSUFFICIENTLY RESUSPENDED RED CELL SUSPENSIONS BUTTONS OF RED BLOOD CELLS REMAINED ON THE BOTTOM OF THE WELLS. THESE CELL BUTTONS WERE ASSESSED AS POSITIVE REACTIONS BY THE TANGO INSTRUMENT. AND AS SHOWN IN ONE PICTURE ONE FALSE NEGATIVE REACTION WITH ERYTYPECELL B OCCURRED. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT ERYTYPECELL A1&B FOR INVESTIGATIONAL TESTING BUT 42 ERYTYPE S ABD+ REV. A1, B PLATES. AT THE TIME WE RECEIVED THE ERYTYPE PLATES THE SUPPOSEDLY DEFECTIVE PRODUCT ERYTYPECELL A1&B WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED 10 OUT OF THE 42 ERYTYPE S ABD+REV. A1, B PLATES WITH THE CURRENT LOT OF ERYTYPECELL A1&B (LOT 8931011-00) ON THE TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS OR INSUFFICIENTLY RESUSPENDED NEGATIVE REACTIONS. WITHIN THE SHEL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8868754 ↗
• MalfunctionAug 7, 2019Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ISSUES WHEN TESTING WITH ERYTYPECELL A1&B ON TANGO OPTIMO. THE CUSTOMER STATED THAT SHE OBSERVED DEBRIS AND JUNK IN THE REVERSE TYPING WHICH CAUSED FALSE POSITIVE RESULTS. THE CUSTOMER PROVIDED IMAGES OF THE TANGO OPTIMO; THESE IMAGES SHOW REACTIONS WHICH WERE SUPPOSED TO BE NEGATIVE. BUT DUE TO INSUFFICIENTLY RESUSPENDED RED BLOOD CELL SUSPENSIONS THERE IS A BUTTON OF RED BLOOD CELLS ON THE BOTTOM OF THE WELL WHICH IS ASSESSED AS A POSITIVE REACTION BY THE TANGO INSTRUMENT. AND AS SHOWN IN ONE PICTURE ONE FALSE NEGATIVE REACTION WITH ERYTYPECELL B OCCURRED. WE ARE WAITING FOR THE MATERIAL RETURNED BY THE CUSTOMER FOR INVESTIGATIONAL TESTING. IN THE MEANTIME OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPECELL A1&B WITH DIFFERENT SAMPLES ON ERYTYPE S ABD+REV.A1, B ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESPECTIVELY FALSE NEGATIVE REACTION. AND ALL NEGATIVE REACTIONS WERE COMPLETELY RE-SUSPENDED. USUALLY, INSUFFICIENTLY RESUSPENDED RED BLOOD CELL SUSPENSIONS CAN EASILY BE DIFFERENTIATED FROM REAL POSITIVE REACTIONS BY A VISUAL ASSESSMENT. A REVIEW OF THE BATCH RECORD DOCUME

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8868753 ↗
• MalfunctionMay 16, 2019Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ERYTYPECELL A1&B, LOT.: 8911011-00 IS GIVING ERRONEOUS RESULTS WITH ERYTYPE S ABD+REV A1B (#8830130) ON TANGO OPTIMO. CELL A1 WELLS WERE NOT INTERPRETED WITH QC FROM IMMUCOR (#236322). CELL B WELLS WERE ALSO SUSPECT. FURTHERMORE THE CUSTOMER REPORTED DECREASING TO MISSING REACTIONS IN REVERSE CELLS WITH ERYTYPECELL A1&B LOT 8911011-00 AND WB CORE QC FROM IMMUCOR LOT 236322; OPENED FROM 2-4 DAYS. "EXTRA REACTIONS" ON A1 OR B CELLS WITH PATIENT SAMPLES WERE ALSO REPORTED. REPEAT OF PATIENT SAMPLES ON ANOTHER TANGO RESULTED AS EXPECTED. REPEAT WITH SAME IMMUCOR QC ON ANOTHER TANGO INSTRUMENT SHOWED THE SAME ISSUE. BEFORE THE ALLEGEDLY DEFECTIVE PRODUCT WAS EXPIRED (MAY 6TH, 2019), OUR QUALITY CONTROL LABORATORY TESTED 12 DIFFERENT EDTA SAMPLES ON TANGO OPTIMO BY USING THE RETAINED SAMPLES OF ERYTYPECELL A1&B AND ERYTYPE S ABD+REV A1B THAT WERE USED BY THE CUSTOMER WHEN THE INCIDENT THAT LEAD TO THE COMPLAINT HAPPENED. ON MAY 7TH, 2019 TWO PATIENT SAMPLES ((B)(6)) ARRIVED AT BMD FOR INVESTIGATIONAL TESTING. BOTH DONOR SAMPLES WERE HAEMOLYSED. AT THAT TIME, 10 MORE DIFFERENT EDTA SAMPLES AND ADDITIONALLY THE SAMPLES FROM THE CUSTOMER WERE TESTED BY OUR QC LAB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8614603 ↗
• MalfunctionApr 11, 2019False Positive Result; Defective Device

  THE CUSTOMER REPORTED ISSUES WITH ERYTYPECELL A1 & B ON TANGO INFINITY. THE CUSTOMER STATED THAT IN TOTAL FOUR SAMPLES WERE AFFECTED WHICH SHOWED FALSE POSITIVE RESULTS WITH ERYTYPECELL A1 RESPECTIVELY ERYTYPECELL B. DUE TO THE DISCREPANCIES BETWEEN FORWARD AND REVERSE TYPING THE ABO BLOOD GROUPS WERE NOT INTERPRETED AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER PROVIDED NEITHER THE COMPLAINT SAMPLE FOR INVESTIAGIONAL TESTING NOR THE SPECIMENS THAT HAD CAUSED INCORRECT RESULTS. BUT THE CUSTOMER PROVIDED THE TANGO INFINITY RESULTS AND IMAGES WHICH CONFIRM THE REPORTED ISSUE. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPECELL A1 & B WITH DIFFERENT SAMPLES ON ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESPECTIVELY QUESTION MARK RESULTS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPECELL A1 & B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. REGARDING THE AFFECTED TANGO INFINITY, THE CUSTOMER PROVI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503430 ↗
• MalfunctionApr 11, 2019False Positive Result; Defective Device

  THE CUSTOMER REPORTED ISSUES WITH ERYTYPECELL A1 & B ON TANGO INFINITY. THE CUSTOMER STATED THAT IN TOTAL FOUR SAMPLES WERE AFFECTED WHICH SHOWED FALSE POSITIVE RESULTS WITH ERYTYPECELL A1 RESPECTIVELY ERYTYPECELL B. DUE TO THE DISCREPANCIES BETWEEN FORWARD AND REVERSE TYPING THE ABO BLOOD GROUPS WERE NOT INTERPRETED AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER PROVIDED NEITHER THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE SPECIMENS THAT HAD CAUSED INCORRECT RESULTS. BUT THE CUSTOMER PROVIDED THE TANGO INFINITY RESULTS AND IMAGES WHICH CONFIRM THE REPORTED ISSUE. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPECELL A1 & B WITH DIFFERENT SAMPLES ON ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESPECTIVELY QUESTION MARK RESULTS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPECELL A1 & B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. REGARDING THE AFFECTED TANGO INFINITY, THE CUSTOMER PROV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503429 ↗
• MalfunctionApr 11, 2019False Positive Result; Defective Device

  THE CUSTOMER REPORTED ISSUES WITH ERY TYPE CELL A1 & B ON TANGO INFINITY. THE CUSTOMER STATED THAT IN TOTAL FOUR SAMPLES WERE AFFECTED WHICH SHOWED FALSE POSITIVE RESULTS WITH ERY TYPE CELL A1 RESPECTIVELY ERY TYPE CELL B. DUE TO THE DISCREPANCIES BETWEEN FORWARD AND REVERSE TYPING THE ABO BLOOD GROUPS WERE NOT INTERPRETED AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER PROVIDED NEITHER THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE SPECIMENS THAT HAD CAUSED INCORRECT RESULTS. BUT THE CUSTOMER PROVIDED THE TANGO INFINITY RESULTS AND IMAGES WHICH CONFIRM THE REPORTED ISSUE. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERY TYPE CELL A1 & B WITH DIFFERENT SAMPLES ON ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESPECTIVELY QUESTION MARK RESULTS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE CELL A1 & B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. REGARDING THE AFFECTED TANGO INFINITY, THE CUST

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503426 ↗
• MalfunctionJun 20, 2018Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED QUESTIONABLE RESULTS IN REVERSE TYPING (+/- ON THE B CELLS) WHEN USING ERYTYPECELL A1&B O TANGO OPTIMO. SOMETIMES THE +/- REACTIONS OCCURRED ON THE A1 CELLS AS WELL. WITH A FRESH SET OF A1 AND B CELLS THIS ISSUE HAS NOT OCCURED ANYMORE. THE CUSTOMER DID NOT PROVIDE THE ERYTYPECELL A1&B THAT HAD CAUSED +/- REACTIONS ON THEIR TANGO OPTIMO FOR INVESTIGATIONAL TESTING. THE CUSTOMER DID ALSO NOT PROVIDE THE REQUESTED IMAGES OF THE +/- REACTIONS. THE COMPLAINED RRBC´S ERYTYPECELL A1&B WERE USED WITHIN QC TESTING IN OUR QUALITY CONTROL LABORATORY WITH DIFFERENT SAMPLES ON TANGO OPTIMO. NO IRREGULARITIES WERE FOUND. THE NEGATIVE REACTIONS WERE CLEARLY NEGATIVE. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT ERYTYPECELL A1&B FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. DATA OF THE INVOLVED TANGO OPTIMO WERE ANALYZED WITH NO INDICATION FOR AN INSTRUMENT MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7617973 ↗
• MalfunctionNov 7, 2017False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS OF THE SERUM GROUPING REAGENT RED BLOOD CELLS ERYTYPECELL A1&B ON TANGO INFINITY. THE CUSTOMER STATED THAT NEGATIVE REVERSE GROUPING IMAGES WERE IDENTIFIED AS +/- BY THE INSTRUMENT. THE CUSTOMER RETURNED NEITHER THE SPECIMEN THAT HAD CAUSED FALSE POSITIVE TEST RESULTS FOR INVESTIGATIONAL TESTING NOR THE SUPPOSEDLY DEFECTIVE PRODUCT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPECELL A1&B WITH DIFFERENT SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPECELL A1&B FUNCTIONS CORRECTLY. 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 WITH NO INDICATION FOR AN INSTRUMENT MALFUNCTION. THE SERVICE ENGINEER CONFIRMED A PROPER FUNCTION OF THE INSTRUMENT BY METROLOGY QUALIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7005467 ↗
• MalfunctionNov 7, 2017False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS OF THE SERUM GROUPING REAGENT RED BLOOD CELLS ERYTYPECELL A1&B ON TANGO INFINITY. THE CUSTOMER STATED THAT NEGATIVE REVERSE GROUPING IMAGES WERE IDENTIFIED AS +/- BY THE INSTRUMENT. THE CUSTOMER RETURNED NEITHER THE SPECIMEN THAT HAD CAUSED FALSE POSITIVE TEST RESULTS FOR INVESTIGATIONAL TESTING NOR THE SUPPOSEDLY DEFECTIVE PRODUCT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPECELL A1&B WITH DIFFERENT SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPECELL A1&B FUNCTIONS CORRECTLY. 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 WITH NO INDICATION FOR AN INSTRUMENT MALFUNCTION. THE SERVICE ENGINEER CONFIRMED A PROPER FUNCTION OF THE INSTRUMENT BY METROLOGY QUALIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7005459 ↗
• MalfunctionNov 7, 2017False Positive Result; Defective Component

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS OF THE SERUM GROUPING REAGENT RED BLOOD CELLS ERY TYPE CELL A1 AND B ON TANGO INFINITY. THE CUSTOMER STATED THAT NEGATIVE REVERSE GROUPING IMAGES WERE IDENTIFIED AS +/- BY THE INSTRUMENT. THE CUSTOMER RETURNED NEITHER THE SPECIMEN THAT HAD CAUSED FALSE POSITIVE TEST RESULTS FOR INVESTIGATIONAL TESTING NOR THE SUPPOSEDLY DEFECTIVE PRODUCT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERY TYPE CELL A1 AND B WITH DIFFERENT SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERY TYPE CELL A1 AND B FUNCTIONS CORRECTLY. 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 WITH NO INDICATION FOR AN INSTRUMENT MALFUNCTION. THE SERVICE ENGINEER CONFIRMED A PROPER FUNCTION OF THE INSTRUMENT BY METROLOGY QUALIFICATION.

  Patient problems: Reaction; Test Result

  MAUDE report 7005458 ↗