Alinity 06P0660Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380740117207), received between Mar 19, 2021 and Nov 3, 2025 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 23449832 ↗
• MalfunctionMay 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ANTI-HBC ON THE ALINITY S PROCESSING MODULE FOR 1 CADAVERIC SAMPLE THAT IS RED IN APPEARANCE. THE RESULTS DID NOT MATCH THE PATIENT¿S HISTORY. THERE WAS NO CONFIRMATORY TESTING PERFORMED AND THE TISSUE WAS DISCARDED. THE FOLLOWING DATA WAS PROVIDED: TESTED ON (B)(6) 2024 ANTI-HBC (B)(6) RESULTS = 5.56 5.45/5.83 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312051 ↗
• MalfunctionDec 1, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HBC RESULTS WHEN COMPARED TO ANOTHER METHOD. THERE WERE 11 REPEAT REACTIVE ALINITY S ANTI-HBC SAMPLES. THE SAMPLES WERE RUN USING DIFFERENT METHODOLOGY (ORTHO HBC ELISA ASSAY) AND ONLY 3 OUT OF THE 11 SAMPLES WERE POSITIVE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) 5.48 / 5.51 / 5.25, ALT ASSAY 3.274 / 6.723, SID (B)(6) 2.89 / 2.84 / 2.77, ALT ASSAY 1.358 / 2.789, SID (B)(6) 1.86 / 1.92 / 1.93, ALT ASSAY 0.103 / 0.211, SID (B)(6) 1.02 / 1.00 / 0.98, ALT ASSAY 0.090 / 0.185, SID (B)(6) 1.61 / 1.56 / 1.59, ALT ASSAY 0.455 / 0.934, SID (B)(6) 1.02 / 1.02 / 1.07, ALT ASSAY 0.649 / 1.333, SID (B)(6) 1.42 / 1.44 / 1.43, ALT ASSAY 0.094 / 0.193, SID (B)(6) 1.07 / 1.03 / 1.02, ALT ASSAY 0.084 / 0.172, SID (B)(6) 1.10 / 0.98 / 1.07, ALT ASSAY 0.088 / 0.181, SID (B)(6) 1.09 / 1.03 / 1.11, ALT ASSAY 0.094 / 0.193, SID (B)(6) 1.64 / 1.67 / 1.64, ALT ASSAY 0.440 / 0.903. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250636 ↗
• MalfunctionDec 1, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HBC RESULTS WHEN COMPARED TO ANOTHER METHOD. THERE WERE 11 REPEAT REACTIVE ALINITY S ANTI-HBC SAMPLES. THE SAMPLES WERE RUN USING DIFFERENT METHODOLOGY (ORTHO HBC ELISA ASSAY) AND ONLY 3 OUT OF THE 11 SAMPLES WERE POSITIVE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) 5.48 / 5.51 / 5.25, ALT ASSAY 3.274 / 6.723; SID (B)(6) 2.89 / 2.84 / 2.77, ALT ASSAY 1.358 / 2.789; SID (B)(6) 1.86 / 1.92 / 1.93, ALT ASSAY 0.103 / 0.211; SID (B)(6) 1.02 / 1.00 / 0.98, ALT ASSAY 0.090 / 0.185; SID (B)(6) 1.61 / 1.56 / 1.59, ALT ASSAY 0.455 / 0.934; SID (B)(6) 1.02 / 1.02 / 1.07, ALT ASSAY 0.649 / 1.333; SID (B)(6) 1.42 / 1.44 / 1.43, ALT ASSAY 0.094 / 0.193; SID (B)(6) 1.07 / 1.03 / 1.02, ALT ASSAY 0.084 / 0.172; SID (B)(6) 1.10 / 0.98 / 1.07, ALT ASSAY 0.088 / 0.181; SID (B)(6) 1.09 / 1.03 / 1.11, ALT ASSAY 0.094 / 0.193; SID (B)(6) 1.64 / 1.67 / 1.64, ALT ASSAY 0.440 / 0.903. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250530 ↗
• MalfunctionNov 3, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY S ANTI-HBC RESULT ON A DONOR. IN (B)(6) 2023 ALINITY WAS REACTIVE; IN (B)(6) 2023 WAS NONREACTIVE; IN (B)(6) 2023 WAS REACTIVE, ANOTHER LABORATORY WAS NEGATIVE FOR ANTI-HBC. RESULTS PROVIDED: (B)(6) 2023 SID (B)(6) = 1.06 / 1.06 / 1.06 S/CO, (B)(6) 2023 SID (B)(6) = 0.84 S/CO, (B)(6) 2023 SID (B)(6) = 1.05 / 1.02 / 1.02 S/CO. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067586 ↗
• MalfunctionOct 30, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY S ANTI-HBC RESULT ON A DONOR. IN (B)(6) 2023 ALINITY WAS REACTIVE; IN (B)(6) 2023 WAS NONREACTIVE; IN (B)(6) 2023 WAS REACTIVE, ANOTHER LABORATORY WAS NEGATIVE FOR ANTI-HBC. RESULTS PROVIDED: (B)(6) 2023 SID (B)(6) = 1.06 / 1.06 / 1.06 S/CO. (B)(6) 2023 SID (B)(6) = 0.84 S/CO. (B)(6) 2023 SID (B)(6) = 1.05 / 1.02 / 1.02 S/CO .NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18028262 ↗
• MalfunctionOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ALINITY S ANTI-HBC RESULT ON A DONOR. THE FOLLOWING RESULTS WERE PROVIDED: DATE: (B)(6) 2023; ASSAY: ANTI-HBC; SID: (B)(6); ALINITY RESULTS: = 1.13 / 1.09 / 1.13 S/CO; NAT RESULT : NEGATIVE. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950481 ↗
• MalfunctionMar 15, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S ANTI-HBC RESULTS ON TWO PATIENT. RESULTS PROVIDED: (B)(6) 2023 SID (B)(6) = 1.08 / 1.14 / 1.12 S/CO, ANOTHER LABORATORY WAS NONREACTIVE (0.98 S/CO), NAT NEGATIVE. (B)(6) 2023 SID (B)(6) = 1.07 / 1.06 / 1.08 S/CO, ANOTHER LABORATORY WAS NONREACTIVE (0.91 S/CO), NAT NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545529 ↗
• MalfunctionMar 15, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NONREACTIVE ALINITY S ANTI-HBC RESULTS ON TWO DONORS. RESULTS PROVIDED: (B)(6) = 0.98 S/CO; ANOTHER LABORATORY¿S ALINITY S = 1.08 / 1.14 / 1.12 S/CO, NAT NEGATIVE. (B)(6) = 0.91 S/CO, ANOTHER LABORATORY¿S ALINITY S = 1.07 / 1.06 / 1.08 S/CO, NAT NEGATIVE. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545418 ↗
• MalfunctionFeb 16, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HBC RESULTS ON MULTIPLE DONORS. THE CUSTOMER STATED THAT SEVEN DONOR SAMPLES TESTED REACTIVE FOR ANTI-HBC IN ONE DAY. THE SAMPLES WERE RECENTRIFUGED, REPEATED AND ALL THE RESULTS REMAINED REACTIVE. THE CUSTOMER DID NOT SEND THE SAMPLES OUT FOR CONFIRMATION, HOWEVER, THE CUSTOMER FELT THAT IT WAS AN EXCESSIVE NUMBER OF REACTIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = REACTIVE; REPEAT RESULT = REACTIVE. SID (B)(6) INITIAL RESULT = REACTIVE; REPEAT RESULT = REACTIVE. SID (B)(6) INITIAL RESULT = REACTIVE; REPEAT RESULT = REACTIVE. SID (B)(6) INITIAL RESULT = REACTIVE; REPEAT RESULT = REACTIVE. SID (B)(6) INITIAL RESULT = REACTIVE; REPEAT RESULT = REACTIVE. SID (B)(6) INITIAL RESULT = REACTIVE; REPEAT RESULT = REACTIVE. SID (B)(6) INITIAL RESULT = REACTIVE; REPEAT RESULT = REACTIVE. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384783 ↗
• MalfunctionJan 5, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HBC RESULT ON FOUR SAMPLES WHEN COMPARED TO THE NAT RESULT. THE FOLLOWING DATA WAS PROVIDED (REACTIVE CUTOFF >1.00 S/CO): SID (B)(6) ALINITY S ANTI-HBC INITIAL 7.99 S/CO, REPEATED 8.34 AND 8.15 S/CO, PANTHER NAT ULTRIO ELITE NONREACTIVE (0.10 S/CO). SID (B)(6) ALINITY S ANTI-HBC INITIAL 3.79 S/CO, REPEATED 3.53 AND 3.76 S/CO, PANTHER NAT ULTRIO ELITE NONREACTIVE (0.08 S/CO). SID (B)(6) ALINITY S ANTI-HBC INITIAL 5.32 S/CO, REPEATED 5.77 AND 5.68 S/CO, PANTHER NAT ULTRIO ELITE NONREACTIVE (0.13 S/CO). SID (B)(6) ALINITY S ANTI-HBC INITIAL 1.06 S/CO, REPEATED 1.06 AND 1.14 S/CO, PANTHER NAT ULTRIO ELITE NONREACTIVE (0.09 S/CO). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16105000 ↗
• InjuryDec 12, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HBC RESULTS FOR ONE CADAVERIC TISSUE DONOR SAMPLE THAT WAS NAT NEGATIVE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SID (B)(6) INITIAL ANTI-HBC RESULT = 6.70 S/CO, REPEATS = 8.55 S/CO AND 8.04 S/CO, HEMOLYSIS WAS 50 MG/DL. THE TISSUE DONATION WAS REJECTED AND NOT COLLECTED OR DISCARDED. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960035 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY ANTI-HBC RESULTS ON MULTIPLE DONOR SPECIMENS. THERE WERE NO ALTERNATE METHOD/CONFIRMATORY RESULTS PROVIDED. THE CUSTOMER PROVIDED THE FOLLOWING SUMMARY OF REPEAT REACTIVE RESULTS ACROSS SEVERAL MONTHS/REAGENT LOTS. NO INDIVIDUAL PATIENT RESULTS WERE PROVIDED. (B)(6) 2021 REPEAT REACTIVE=57, (B)(6) 2021 REPEAT REACTIVE=56, (B)(6) 2021 REPEAT REACTIVE=47, (B)(6) 2021 REPEAT REACTIVE=47, (B)(6) 2021 REPEAT REACTIVE=56, (B)(6) 2021 REPEAT REACTIVE=42. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355406 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY ANTI-HBC RESULTS ON MULTIPLE DONOR SPECIMENS. THERE WERE NO ALTERNATE METHOD/CONFIRMATORY RESULTS PROVIDED. THE CUSTOMER PROVIDED THE FOLLOWING SUMMARY OF REPEAT REACTIVE RESULTS ACROSS SEVERAL MONTHS/REAGENT LOTS. NO INDIVIDUAL PATIENT RESULTS WERE PROVIDED. (B)(6) 2021 REPEAT REACTIVE=57. (B)(6) 2021 REPEAT REACTIVE=56. (B)(6) 2021 REPEAT REACTIVE=47. (B)(6) 2021 REPEAT REACTIVE=47. (B)(6) 2021 REPEAT REACTIVE=56. (B)(6) 2021 REPEAT REACTIVE=42. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355291 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED (B)(6) ALINITY S ANTI-HBC RESULTS ON MULTIPLE DONOR SPECIMENS. THE RESULTS PROVIDED WERE: THERE WERE NO REPEAT RESULTS PROVIDED. ON (B)(6) 2021, (B)(6). THE ALINITY S PROCESSING MODULE NOT IN TEST OF RECORD BEFORE (B)(6) 2021. THOSE DATA PROVIDED (B)(6) 2020 FOR VALIDATION ON ALINITY S PROCESSING MODULE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355220 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY ANTI-HBC RESULTS ON MULTIPLE DONOR SPECIMENS. THERE WERE NO ALTERNATE METHOD/CONFIRMATORY RESULTS PROVIDED. THE CUSTOMER PROVIDED THE FOLLOWING SUMMARY OF REPEAT REACTIVE RESULTS ACROSS SEVERAL MONTHS/REAGENT LOTS. NO INDIVIDUAL PATIENT RESULTS WERE PROVIDED. JAN2021 REPEAT REACTIVE=(B(*6) 2021 REPEAT REACTIVE=(B)(6) 2021 REPEAT REACTIVE=47 (B)(6) 2021 REPEAT REACTIVE=47 (B)(6) 2021 REPEAT REACTIVE=56 (B)(6) 2021 REPEAT REACTIVE=42 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354905 ↗
• MalfunctionMar 27, 2021False Positive Result; False Positive Result

  THE CUSTOMER GENERATED (B)(6) ALINITY S ANTI-HBC RESULTS FOR SEVERAL ORGAN TRANSPLANT DONORS IN COMPARISON TO ANOTHER METHOD (GRIFOLS' PANTHER NAT). THE FOLLOWING INFORMATION WAS PROVIDED: ALINITY S ANTI-HBC: SID (B)(6): INITIAL RESULT: (B)(6); SUPPLEMENTAL TESTING WITH ANOTHER METHOD (EIA) (B)(6). THIS SAMPLE WAS TAKEN PREMORTEM. SID (B)(6): INITIAL RESULT: (B)(6); SUPPLEMENTAL TESTING WITH ANOTHER METHOD (EIA) (B)(6). THIS SAMPLE WAS TAKEN PREMORTEM. SID (B)(6): INITIAL RESULT: (B)(6). THIS SAMPLE WAS TAKEN POSTMORTEM. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ORGAN TRANSPLANTS WERE DELAYED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579723 ↗
• MalfunctionMar 19, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED AN INCREASE IN REPEAT (B)(6) RATES IN THE ALINITY S BLOOD SCREENING ASSAYS (ANTI-HBC, HTLV I/II, HIV AG/AB, AND ANTI-HCV) COMPARED TO THE PRISM BLOOD SCREENING ASSAYS FROM (B)(6) 2021 TO (B)(6) 2021. THE CUSTOMER STARTED REPORTING BLOOD SCREEN RESULTS ON THE ALINITY S SYSTEM ON (B)(6) 2021 AND PRIOR TO THAT WAS USING THE PRISM SYSTEM. THE CUSTOMER ALSO NOTED SEVERAL DONORS WERE REPEAT (B)(6) ON ALINITY S WHICH WAS INCONSISTENT WITH THEIR DONOR TESTING HISTORY AS COMPARED TO (B)(6) ON PRISM. THE FOLLOWING DATA WAS PROVIDED FOR THE NUMBER OF FALSE REPEAT (B)(6) DONORS ON THE ALINITY S BLOOD SCREENING ASSAYS COMPARED TO NONREACTIVE RESULTS OBTAINED ON THE PRISM DURING PREVIOUS DONATIONS BY THE SAME DONORS (UNIT NUMBER/DONOR NUMBER): ALINITY S ANTI-HBC (REPEAT (B)(6)) = 9 UNITS/DONORS: (B)(6) ON (B)(6) 2021, (B)(6) ON (B)(6) 2021, (B)(6) ON (B)(6) 2021, (B)(6). ALINITY S ANTI-HCV (REPEAT (B)(6)) = 6 UNITS/DONORS: (B)(6) ON (B)(6) 2021, ORTHO ANTI-HCV = WAS (B)(6), NAT HCV = (B)(6). (B)(6) ON (B)(6) 2021, ORTHO ANTI-HCV = (B)(6), NAT HCV = (B)(6). (B)(6) ON (B)(6) 2021, ORTHO ANTI-HCV = (B)(6), NAT HCV = (B)(6). (B)(6) ON (B)(6) 2021, NAT HCV = (B)(6), REDRAW (B)(6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11526799 ↗