Alinity 06P0760Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00380740117214), received between Mar 19, 2021 and Mar 9, 2026 — classified as 5 injuries, 31 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (36 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR MULTIPLE DONOR SAMPLES THAT WERE WESTERN BLOT NEGATIVE. THE FOLLOWING INFORMATION WAS OBTAINED; HOWEVER, NO SPECIFIC DONOR RESULTS WERE PROVIDED. ALL RESULTS WERE INITIAL REACTIVE, REPEAT REACTIVE, AND WESTERN BLOT NEGATIVE. SIDS ON INSTRUMENT (B)(6): SAMPLE ID (B)(6) - (B)(6) 2026, SAMPLE ID (B)(6)- (B)(6) 2026, SAMPLE ID (B)(6) - (B)(6) 2026, SAMPLE ID (B)(6) - (B)(6) 2026, SAMPLE ID (B)(6) - (B)(6) 2026, SAMPLE ID (B)(6) - (B)(6) 2025, SAMPLE ID (B)(6) - (B)(6) 2025, SAMPLE ID (B)(6) - (B)(6) 2025, SAMPLE ID (B)(6) - (B)(6) 2025. SID ON INSTRUMENT (B)(6): SAMPLE ID (B)(6) - (B)(6) 2026 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552155 ↗
• MalfunctionNov 3, 2025False Positive Result; False Positive Result

  AN ARTICLE BY SARA O. DIONNE, HILLARY C. S. R. AKANA, MICHAEL REAL, KIMBERLY A. ELLIOTT, BRENDEN R. O¿NEALE ¿INCREASED SEROLOGIC REACTIVITY WITH AUTOMATED CMIA TESTING AND ITS IMPLICATIONS FOR DECEASED DONOR ELIGIBILITY DETERMINATION IN THE UNITED STATES¿, CELL TISSUE BANK (2025) 26:40 MENTIONS REPEAT REACTIVE RESULTS FOR SAMPLES WITH ALINITY S HIV AG/AB COMBO, ALINITY S HTLV I/II, ALINITY S ANTI-HCV, ALINITY S HBSAG, AND ALINITY S ANTI-HBC. IT ALSO STATES THAT SOME SAMPLES WERE DISCREPANT TO NAT. THESE RESULTS COULD LEAD TO REJECTION OF DONATED TISSUE SAMPLES. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449288 ↗
• MalfunctionOct 16, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR THREE DONORS. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): ON (B)(6) 2025, SID(B)(6), (CADAVERIC SAMPLE): INITIAL RESULT = 2.34 S/CO, REPEAT RESULTS = 3.29 S/CO, 1.55 S/CO WESTERN BLOT RESULT = NEGATIVE. ON (B)(6) 2025, SID(B)(6), (CADAVERIC SAMPLE): INITIAL RESULT = 1.10 S/CO, REPEAT RESULTS = 1.23 S/CO, 0.26 S/CO WESTERN BLOT RESULT = NEGATIVE. ON (B)(6) 2025, SID(B)(6): INITIAL RESULT = 3.84 S/CO, REPEAT RESULTS = 4.18 S/CO, 3.93 S/CO WESTERN BLOT RESULT = INDETERMINATE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312632 ↗
• MalfunctionAug 18, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULT ON A PATIENT (SID (B)(6) THAT WAS NEGATIVE BY SUPPLEMENTAL TESTING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825533 ↗
• MalfunctionMar 4, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS ON SEVERAL PATIENTS, WHICH WERE CONFIRMED NEGATIVE BY WESTERN BLOT TESTING. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL=1.30 S/CO (> OR =1.00 S/CO=REACTIVE) /REPEATED=1.38 S/CO AND 1.46 S/CO ON (B)(6) 2025 SID (B)(6) INITIAL=3.39 S/CO /REPEATED=3.78 S/CO AND 3.43 S/CO /REPEATED ON (B)(6) 2025=0.18 S/CO (< 1.00 S/CO=NONREACTIVE). ON (B)(6) 2025 SID (B)(6) INITIAL=1.80 S/CO /REPEATED=REACTIVE (NO ACTUAL RESULTS PROVIDED). ON (B)(6) 2025 SID (B)(6) INITIAL=1.64 S/CO /REPEATED=REACTIVE (NO ACTUAL RESULTS PROVIDED). ON (B)(6) 2025 SID (B)(6) INITIAL=3.78 S/CO /REPEATED=REACTIVE (NO ACTUAL RESULTS PROVIDED). ON (B)(6) 2025 SID (B)(6) INITIAL=1.25 S/CO /REPEATED=REACTIVE (NO ACTUAL RESULTS PROVIDED). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514828 ↗
• MalfunctionFeb 24, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR MULTIPLE DONOR SAMPLES THAT WERE WESTERN BLOT NEGATIVE. THE CUSTOMER NOTED AN INCREASE IN REACTIVE RESULTS RECENTLY. NO SPECIFIC DONOR INFORMATION OR DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445226 ↗
• MalfunctionFeb 24, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR MULTIPLE DONOR SAMPLES THAT WERE WESTERN BLOT NEGATIVE. THE CUSTOMER NOTED AN INCREASE IN REACTIVE RESULTS RECENTLY. NO SPECIFIC DONOR INFORMATION OR DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445225 ↗
• MalfunctionFeb 24, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR MULTIPLE DONOR SAMPLES THAT WERE WESTERN BLOT NEGATIVE. THE CUSTOMER NOTED AN INCREASE IN REACTIVE RESULTS RECENTLY. NO SPECIFIC DONOR INFORMATION OR DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445223 ↗
• MalfunctionFeb 24, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR MULTIPLE DONOR SAMPLES THAT WERE WESTERN BLOT NEGATIVE. THE CUSTOMER NOTED AN INCREASE IN REACTIVE RESULTS RECENTLY. NO SPECIFIC DONOR INFORMATION OR DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445222 ↗
• MalfunctionJun 26, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HTLV I/II RESULTS GENERATED ON THE ALINITY S SYSTEM FOR 4 CADAVERIC TISSUE DONORS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024, SID (B)(6): INITIAL HTLV I/II RESULT = 3.19 S/CO; REPEAT RESULTS = 3.58 AND 4.35 S/CO; IMMUNOBLOT RESULT = NEGATIVE; TISSUE DISPOSITION = NOT PROVIDED. (B)(6) 2024, SID (B)(6): INITIAL HTLV I/II RESULT = 3.94 S/CO; REPEAT RESULTS = 2.83 AND 2.00 S/CO; IMMUNOBLOT RESULT = NEGATIVE; TISSUE DISPOSITION = NOT PROVIDED. (B)(6) 2024, SID (B)(6): INITIAL HTLV I/II RESULT = 4.17 S/CO; REPEAT RESULTS = 4.40 AND 4.44 S/CO; IMMUNOBLOT RESULT = NEGATIVE; TISSUE DISPOSITION = NOT PROVIDED. (B)(6) 2024, SID(B)(6): INITIAL HTLV I/II RESULT = 1.29 S/CO; REPEAT RESULTS = 1.19 AND 0.14 S/CO; IMMUNOBLOT RESULT = NEGATIVE; TISSUE DISPOSITION = NOT PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620934 ↗
• MalfunctionApr 11, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HBSAG AND HTLV I/II RESULTS FOR 12 DONORS. THE CUSTOMER STATED DONORS WERE TESTED WITH ANOTHER METHOD AND NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER STATES THEY HAVE HAD 10 REPEAT REACTIVE HBSAG(SINCE JAN2024) AND 2 REPEAT REACTIVE HTLV I/II(IN MARCH2024) THAT WERE SENT FOR CONFIRMATORY NAT TESTING THAT WAS NEGATIVE. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC RESULT INFORMATION. ADDITIONAL INFORMATION FROM 10APR2024: SINCE THE BEGINNING OF APRIL, 5 MORE REPEAT REACTIVE ALINITY S HBSAG AND 2 MORE REPEAT REACTIVE HTLV. THERE WAS NO FURTHER RESULT INFORMATION PROVIDED OR NONREACTIVE RESULT PROVIDED. ALL 19 TOTAL SAMPLES WERE CADAVERIC AND SLIGHTLY HEMOLYZED. ADDITIONAL INFORMATION FROM 12APR2024: ALL HBSAG REACTIVE SAMPLES WERE REJECTED FOR TISSUE DONATIONS. FOR HTLV REACTIVE DISPOSITION STATUS NOT PROVIDED. HTLV IMMUNOBLOT RESULTS FOR THE TWO ADDITIONAL SAMPLES FROM APRIL WERE NEGATIVE. ADDITIONAL INFORMATION FROM 15APR2024: THE SAMPLE PROVIDED BELOW ARE SPECIFIC RESULTS/INFORMATION FROM THE TESTING IN APRIL. 3 NEW HBSAG POSITIVE SAMPLES ARE INCLUDED THAT WERE RAN ON (B)(6) 2024. THE OTHER 5 HBSAG AND 2 HTLV ARE SPECIFIC RESULTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093508 ↗
• MalfunctionApr 11, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HBSAG AND HTLV I/II RESULTS FOR 12 DONORS. THE CUSTOMER STATED DONORS WERE TESTED WITH ANOTHER METHOD AND NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER STATES THEY HAVE HAD 10 REPEAT REACTIVE HBSAG(SINCE (B)(6) 2024) AND 2 REPEAT REACTIVE HTLV I/II(IN (B)(6) 2024) THAT WERE SENT FOR CONFIRMATORY NAT TESTING THAT WAS NEGATIVE. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC RESULT INFORMATION. ADDITIONAL INFORMATION FROM 10APR2024: SINCE THE BEGINNING OF APRIL, 5 MORE REPEAT REACTIVE ALINITY S HBSAG AND 2 MORE REPEAT REACTIVE HTLV. THERE WAS NO FURTHER RESULT INFORMATION PROVIDED OR NONREACTIVE RESULT PROVIDED. ALL 19 TOTAL SAMPLES WERE CADAVERIC AND SLIGHTLY HEMOLYZED. ADDITIONAL INFORMATION FROM 12APR2024: ALL HBSAG REACTIVE SAMPLES WERE REJECTED FOR TISSUE DONATIONS. FOR HTLV REACTIVE DISPOSITION STATUS NOT PROVIDED. HTLV IMMUNOBLOT RESULTS FOR THE TWO ADDITIONAL SAMPLES FROM APRIL WERE NEGATIVE. ADDITIONAL INFORMATION FROM 15APR2024: THE SAMPLE PROVIDED BELOW ARE SPECIFIC RESULTS/INFORMATION FROM THE TESTING IN (B)(6) NEW HBSAG POSITIVE SAMPLES ARE INCLUDED THAT WERE RAN ON (B)(6) 2024. THE OTHER 5 HBSAG AND 2 HTLV ARE SPECIFIC RESU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093400 ↗
• MalfunctionJan 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR TWO DONORS. THE CUSTOMER STATED BOTH DONORS WERE TESTED WITH ANOTHER METHOD AND NEGATIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: 12DEC2023 SID (B)(6) INITIAL RESULT = REACTIVE; REPEAT RESULT = REACTIVE ANOTHER METHOD = NEGATIVE. 13DEC2023 SID (B)(6) INITIAL RESULT = REACTIVE; REPEAT RESULT = REACTIVE ANOTHER METHOD = NEGATIVE. THERE WAS NO IMPACT TO DONOR MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441443 ↗
• MalfunctionOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS ON TWO DONORS. THE FOLLOWING RESULTS WERE PROVIDED: DATE, ASSAY, SID, ALINITY RESULTS, AND NAT RESULT. (B)(6) 2023, HTLV I/II, (B)(6), = 1.28 / 1.12 / 1.25 S/CO AND NEGATIVE. (B)(6) 2023, HTLV I/II, (B)(6), = 1 / 1.01 / 0.98 S/CO AND NEGATIVE . NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951776 ↗
• MalfunctionSep 18, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HTLV I/II RESULTS FOR TWO CADAVERIC TISSUE DONORS. THE FOLLOWING DATA WAS PROVIDED (INTERPRETATION OF RESULTS: <1.00 IS NONREACTIVE): (B)(6) 2023 SID (B)(6) INITIAL RESULT = 5.24 S/CO, REPEATS = 6.11 S/CO AND 6.57 S/CO. ADDITIONAL LABORATORY DATA WAS PROVIDED: HIV AG/AB = 0.08 S/CO, HBSAG = 0.20 S/CO, ANTI-HCV = 0.04 S/CO, ANTI-HBC = 0.09 S/CO, HEMOLYSIS RESULT = 100 NG/DL. (B)(6) 2023 SID (B)(6) INITIAL RESULT = 2.03 S/CO, REPEATS = 1.64 S/CO AND 0.23 S/CO, REPEAT WITH ANOTHER LOT NUMBER = 0.20 S/CO. ADDITIONAL LABORATORY DATA WAS PROVIDED: HIV AG/AB = 0.06 S/CO, HBSAG = 0.35 S/CO, ANTI-HCV = 0.02 S/CO, ANTI-HBC = 0.10 S/CO, HEMOLYSIS RESULT = 20 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17766564 ↗
• MalfunctionMay 16, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS ON MULTIPLE DONORS. RESULTS PROVIDED: SID: DATE: INITIAL / REPEAT: WESTERN BLOT: (B)(6) 03MAR2023 = 2.01 / 1.9 / 2.01 N. (B)(6) 03MAR2023 = 1.01 / 1.06 N. (B)(6) 03MAR2023 = 1.13 / 1.15 N. (B)(6) 05MAR2023 = 1.29 / 1.24 / 1.26 N. (B)(6) 07MAR2023 = 1.21 / 1.18 / 1.18 INDT. (B)(6) 24MAR2023 = 3.31 / 2.87 / 3.24 N (B)(6) 11MAR2023 = 1.57 / 1.57 / 1.6 N. (B)(6) 11MAR2023 = 1.55 / 1.36 / 1.46 N. (B)(6) 10MAR2023 = 1.18 / 1.02 / 1.02 N. (B)(6) 08MAR2023 = 2.19 / 2.2 / 2.09 N. (B)(6) 08MAR2023 = 1.1 / 1.04 / 1.12 N. (B)(6) 14MAR2023 = 1.17 / 1.13 / 1.14 N. (B)(6) 14MAR2023 = 1.18 / 1.13 / 1.15 N. (B)(6) 08MAR2023 = 1.27 / 1.30 / 1.31 N. (B)(6) 29MAR2023 = 1.07 / 1.01 INDT. (B)(6) 10MAR2023 = 1.07 / 1.03 INDT. (B)(6) 11MAR2023 = 2.54 / 2.62 / 2.72 INDT. (B)(6) 26MAR2023 = 7.08 / 7.32 / 8.14 INDT. UOM = S/CO. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939633 ↗
• MalfunctionMay 16, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS ON MULTIPLE DONORS. RESULTS PROVIDED: SID; DATE; INITIAL / REPEAT; WESTERN BLOT. (B)(6); (B)(6) 2023; = 2.01 / 1.9 / 2.01; N. (B)(6), (B)(6) 2023; = 1.01 / 1.06; N. (B)(6); (B)(6) 2023; = 1.13 / 1.15; N. (B)(6); (B)(6) 2023; = 1.29 / 1.24 / 1.26; N. (B)(6); (B)(6) 2023; = 1.21 / 1.18 / 1.18; INDT. (B)(6); (B)(6) 2023; = 3.31 / 2.87 / 3.24; N. (B)(6); (B)(6) 2023; = 1.57 / 1.57 / 1.6; N. (B)(6); (B)(6) 2023; = 1.55 / 1.36 / 1.46; N. (B)(6); (B)(6) 2023; = 1.18 / 1.02 / 1.02; N. (B)(6); (B)(6) 2023; = 2.19 / 2.2 / 2.09; N. (B)(6); (B)(6) 2023; = 1.1 / 1.04 / 1.12; N. (B)(6); (B)(6) 2023; = 1.17 / 1.13 / 1.14; N. (B)(6); (B)(6) 2023; = 1.18 / 1.13 / 1.15; N. (B)(6); (B)(6) 2023; = 1.27 / 1.30 / 1.31; N (B)(6); (B)(6) 2023; = 1.07 / 1.01; INDT. (B)(6); (B)(6) 2023; = 1.07 / 1.03; INDT. (B)(6); (B)(6) 2023; = 2.54 / 2.62 / 2.72; INDT. (B)(6); (B)(6) 2023; = 7.08 / 7.32 / 8.14; INDT. UOM = S/CO. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939602 ↗
• MalfunctionMay 8, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HTLV I/II RESULTS FOR FIVE CADAVERIC SAMPLES THAT WERE NAT NEGATIVE. THE FOLLOWING DATA WAS PROVIDED: 20MAR2023 SID (B)(6) AS1264 INITIAL RESULT = 1.43 S/CO, REPEATS = 1.30 S/CO AND 1.14 S/CO, NAT = NEGATIVE. 18MAR2023 SID (B)(6) AS1264 INITIAL RESULT = 8.36 S/CO, REPEATS = 16.24 S/CO AND 15.99 S/CO, NAT = NEGATIVE. 14MAR2023 SID (B)(6) AS1264 INITIAL RESULT = 3.66 S/CO, REPEATS = 3.51 S/CO AND 1.24 S/CO, NAT = NEGATIVE. 12MAR2023 SID (B)(6) AS1264 INITIAL RESULT = 1.34 S/CO, REPEATS = 1.20 S/CO AND 1.24 S/CO, NAT = NEGATIVE, 31MAR2023 SID (B)(6) AS1300 INITIAL RESULT = 2.18 S/CO, REPEATS = 1.99 S/CO AND 2.08 S/CO, NAT = NEGATIVE. THE CUSTOMER IS UNABLE TO PROVIDE FINAL TISSUE DISPOSITION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885298 ↗
• MalfunctionApr 6, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS ON MULTIPLE DONORS. RESULTS PROVIDED: SID: INITIAL REPEAT WESTERN BLOT (B)(6): REACTIVE REACTIVE / REACTIVE NEG (B)(6): REACTIVE REACTIVE / NON-REACTIVE NEG (B)(6): REACTIVE REACTIVE / NON-REACTIVE NEG (B)(6): REACTIVE REACTIVE / REACTIVE NEG (B)(6) :REACTIVE REACTIVE / REACTIVE INDETERMINATE NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688402 ↗
• InjurySep 29, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS ON A CADAVERIC TISSUE DONOR SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SAMPLE ID (B)(6) INITIAL RESULT = 2.54; REPEAT = 3.46 AND 4.17 S/CO , WESTERN BLOT = NEGATIVE, THE DONATED TISSUE WAS DISCARDED DUE TO THE FALSE REACTIVE HTLV I/II RESULTS. THE SAMPLE APPEARANCE WAS NORMAL AND SPUN ACCORDING TO THE PACKAGE INSERT REQUIREMENTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506819 ↗
• InjurySep 29, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS ON A CADAVERIC TISSUE DONOR SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID 171649 INITIAL RESULT = 4.02; REPEAT = 3.08 AND 3.03 S/CO WESTERN BLOT = NEGATIVE. THE DONATED TISSUE WAS DISCARDED DUE TO THE FALSE REACTIVE HIV RESULTS. THE SAMPLE APPEARANCE WAS NORMAL AND SPUN ACCORDING TO THE PACKAGE INSERT REQUIREMENTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506757 ↗
• InjurySep 29, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SAMPLE ID (B)(6) INITIAL RESULT = 1.06; REPEAT = 2.32 AND 1.73 S/CO, WESTERN BLOT = NEGATIVE. THE DONATED TISSUE WAS DISCARDED DUE TO THE FALSE REACTIVE HTLV I/II RESULTS. THE SAMPLE APPEARANCE WAS NORMAL AND SPUN ACCORDING TO THE PACKAGE INSERT REQUIREMENTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506728 ↗
• MalfunctionSep 29, 2022False Positive Result; False Positive Result

  UPDATE: ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON 22NOV2022. AN ADDITIONAL SAMPLE ID GENERATED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FROM A CADAVERIC TISSUE DONOR. CUSTOMER REPORTED A CADAVERIC SAMPLE REPEATEDLY REACTIVE, NAT NEGATIVE. SAMPLE ID (B)(6), 71-YEAR-OLD FEMALE. CAUSE OF DEATH CARDIAC ARREST. SAMPLE RESULTS = 3.18 S/CO, 3.27 S/CO, AND 1.48 S/CO. WESTERN BLOT WAS NEGATIVE, AND TISSUE WAS ACCEPTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506721 ↗
• InjurySep 29, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS ON A CADAVERIC TISSUE DONOR SAMPLE. THE FOLLOWING DATA WAS PROVIDED: 11SEP2022 SAMPLE ID (B)(6) INITIAL RESULT = 2.55; REPEAT = 3.39 AND 3.76 S/CO. WESTERN BLOT = NEGATIVE. THE DONATED TISSUE WAS DISCARDED DUE TO THE FALSE REACTIVE HTLV I/II RESULTS. THE SAMPLE APPEARANCE WAS NORMAL AND SPUN ACCORDING TO THE PACKAGE INSERT REQUIREMENTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506685 ↗
• InjurySep 29, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS ON A CADAVERIC TISSUE DONOR SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SAMPLE ID 171268 INITIAL RESULT = 2.64; REPEAT = 3.04 AND 2.65 S/CO WESTERN BLOT = NEGATIVE. THE DONATED TISSUE WAS DISCARDED DUE TO THE FALSE REACTIVE HTLV I/II RESULTS. THE SAMPLE APPEARANCE WAS NORMAL AND SPUN ACCORDING TO THE PACKAGE INSERT REQUIREMENTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506611 ↗