Alinity 06P0460Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00380740117191), received between Mar 19, 2021 and Nov 3, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (25 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 34 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 23449241 ↗
• MalfunctionJan 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HCV RESULTS FOR DONOR SAMPLES WHICH WERE NOT CONSISTENT WITH NAT TESTING. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE):SAMPLE ID (B)(6) COLLECTED ON (B)(6) 2024(B)(6) 2024 SAMPLE RUN AND RESULTS ARE REPEAT REACTIVE. INITIAL RESULT ON ANALYZER (B)(6) = 2.32 S/CO, REPEAT RESULTS ON ANALYZER (B)(6) = 2.65 S/CO, 2.79 S/CONAT RESULT ON COBAS = NONREACTIVECONFIRMATORY ORTHO EIA RESULT = REACTIVESAMPLE TESTED ON ALL THREE IN-HOUSE ALINITY ANALYZERS ON (B)(6) 2025 FOR ANTI-HCV II AND ALL 3 RESULTS = NONREACTIVE X3 AS FOLLOWS:RESULT ON AS1233 = 0.03, RESULT ON AS1234 = 0.03, RESULT ON AS1215 = 0.04SAMPLE ID (B)(6) COLLECTED ON (B)(6) 2024(B)(6) 2024 SAMPLE RUN AND RESULTS ARE REPEAT REACTIVE. INITIAL RESULT = 2.19 S/CO, REPEAT RESULTS = 2.28 S/CO, 2.37 S/CONAT RESULT ON COBAS = NONREACTIVECONFIRMATORY ORTHO EIA RESULT = REACTIVESAMPLE TESTED ON ALL THREE IN-HOUSE ALINITY ANALYZERS ON (B)(6) 2025 FOR ANTI-HCV II AND ALL 3 RESULTS = NONREACTIVE X3 AS FOLLOWS:RESULT ON (B)(6) = 0.03, RESULT ON (B)(6) = 0.03, RESULT ON (B)(6) = 0.04 THERE WAS NO IMPACT TO DONOR OR PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266198 ↗
• MalfunctionNov 15, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY S ANTI-HCV RESULTS GENERATED ON TWO ALINITY S SYSTEMS (B)(6) DURING A SENSITIVITY/SPECIFICITY STUDY FOR MULTIPLE SAMPLES WHEN COMPARED TO ALINITY S ANTI-HCV II AND CONFIRMATORY TESTING. THE CUSTOMER CONFIRMED THE NEW RESULT VALUES DID NOT CALL INTO QUESTION ANY PREVIOUSLY REPORTED RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) ANTI-HCV (ON (B)(6) RESULTS = 2.16 S/CO, 1.96 S/CO, 1.98 S/CO, ANTI-HCV II RESULT = 0.03 S/CO, CONFIRMATORY RESULT = NONREACTIVE. (B)(6) ANTI-HCV (ON (B)(6) RESULTS = 1.93 S/CO (ON A DIFFERENT LOT), 2.09 S/CO, 1.70 S/CO, ANTI-HCV II RESULT = 0.03 S/CO, CONFIRMATORY RESULT = NONREACTIVE. (B)(6) ANTI-HCV RESULTS (ON (B)(6) = 1.56 S/CO, 1.60 S/CO, 1.56 S/CO, ANTI-HCV II RESULT = 0.04 S/CO, CONFIRMATORY RESULT = NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693922 ↗
• MalfunctionNov 15, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY S ANTI-HCV RESULTS GENERATED ON TWO ALINITY S SYSTEMS (B)(6) DURING A SENSITIVITY/SPECIFICITY STUDY FOR MULTIPLE SAMPLES WHEN COMPARED TO ALINITY S ANTI-HCV II AND CONFIRMATORY TESTING. THE CUSTOMER CONFIRMED THE NEW RESULT VALUES DID NOT CALL INTO QUESTION ANY PREVIOUSLY REPORTED RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6), ANTI-HCV (ON (B)(6) RESULTS = 4.01 S/CO, 3.77 S/CO, 3.77 S/CO, ANTI-HCV II RESULT = 0.02 S/CO, CONFIRMATORY RESULT = NONREACTIVE. (B)(6), ANTI-HCV (ON (B)(6) RESULTS = 1.15 S/CO, 1.08 S/CO, 1.03 S/CO, ANTI-HCV II RESULT = 0.02 S/CO, CONFIRMATORY RESULT = NONREACTIVE. (B)(6), ANTI-HCV (ON (B)(6) RESULTS = 2.42 S/CO, 2.39 S/CO, 2.24 S/CO, ANTI-HCV II RESULT = 0.04 S/CO, CONFIRMATORY RESULT = NONREACTIVE. (B)(6), ANTI-HCV (ON (B)(6) RESULTS = 1.37 S/CO, 1.49 S/CO, 1.43 S/CO, ANTI-HCV II RESULT = 0.03 S/CO, CONFIRMATORY RESULT = NONREACTIVE. (B)(6), ANTI-HCV (ON (B)(6) RESULTS = 1.12 S/CO, 1.21 S/CO, 1.11 S/CO, ANTI-HCV II RESULT = 0.02 S/CO, CONFIRMATORY RESULT = NONREACTIVE. (B)(6), ANTI-HCV (ON (B)(6) RESULTS = 1.93 S/CO, 2.09 S/CO AND 1.70 S/CO ON A DIFFERENT LOT, ANTI-HCV II RESULT = 0.03 S/CO, CONFIRMATORY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693921 ↗
• MalfunctionOct 18, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HCV RESULTS GENERATED ON THE ALINITY S PROCESSING MODULE FOR NINE DONORS AND/OR STEM CELL PATIENT SAMPLES WHICH WERE NONREACTIVE WITH THE NAT ULTRIO. THE DONOR SAMPLES WITH NONREACTIVE NAT ULTRIO RESULT WERE CONFIRMED AS POSITIVE BY SUPPLEMENTAL TESTING; HOWEVER, THE STEM CELL PATIENT SAMPLES DO NOT GET SENT OUT FOR SUPPLEMENTAL TESTING. THE NINE SAMPLES WERE BLINDED AS THEY WERE USED FOR A VALIDATION STUDY; THEREFORE, IT IS UNKNOWN WHICH OF THE NINE SAMPLES WERE DONOR SAMPLES OR STEM CELL PATIENT SAMPLES. THE CUSTOMER PROVIDED ONE EXAMPLE. (B)(6) 2024 SID (B)(6) RESULT = 4.67 S/CO (REACTIVE); NAT ULTRIO = NONREACTIVE; NO SUPPLEMENTAL TESTING; THERE WAS NO IMPACT TO DONOR/PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479564 ↗
• MalfunctionOct 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HCV RESULTS WHEN COMPARED TO ANOTHER METHOD FOR ONE DONOR SAMPLE. THIS DONOR SAMPLE PREVIOUSLY TESTED REPEAT REACTIVE ON ALINITY S HCV (6P04) AND WAS A STORED SAMPLE. THE SAMPLE WAS PULLED AND USED FOR THE VALIDATION STUDIES FOR A DIFFERENT ASSAY (ALINITY S HCV II (4W56). THE FOLLOWING RESULTS WERE PROVIDED: ALINITY S ANTI-HCV ((B)(6) 2024) INITIAL RESULT 2.85 S/CO, REPEATED 2.48 AND 2.33 S/CO (REPEAT REACTIVE), ORHO HCV REPEAT REACTIVE, NAT NEGATIVE, ALINITY S ANTI-HCV II ((B)(6) 2024) INITIAL RESULT 0.01 S/CO, REPEATED 0.01 AND 0.01 S/CO (NEGATIVE). THE SAMPLE WAS TESTED AGAIN FOR INVESTIGATION PURPOSE AND THE FOLLOWING DATA WAS PROVIDED: ALINITY S ANTI-HCV (INVESTIGATION USING SERUM (B)(6) 2024) INITIAL RESULT 2.17 S/CO, REPEATED 1.39 AND 1.28 S/CO, ALINITY S ANTI-HCV (INVESTIGATION USING PLASMA (B)(6) 2024) INITIAL RESULT 2.50 S/CO, REPEATED 2.63 AND 2.67 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440816 ↗
• MalfunctionOct 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HCV RESULTS WHEN COMPARED TO ANOTHER METHOD FOR ONE DONOR SAMPLE. THIS DONOR SAMPLE PREVIOUSLY TESTED REPEAT REACTIVE ON ALINITY S HCV (6P04) AND WAS A STORED SAMPLE. THE SAMPLE WAS PULLED AND USED FOR THE VALIDATION STUDIES FOR A DIFFERENT ASSAY (ALINITY S HCV II (4W56). THE FOLLOWING RESULTS WERE PROVIDED: ALINITY S ANTI-HCV (B)(6) 2024) INITIAL RESULT 2.85 S/CO, REPEATED 2.48 AND 2.33 S/CO (REPEAT REACTIVE), ORHO HCV REPEAT REACTIVE, NAT NEGATIVE, ALINITY S ANTI-HCV II (B)(6) 2024) INITIAL RESULT 0.01 S/CO, REPEATED 0.01 AND 0.01 S/CO (NEGATIVE). THE SAMPLE WAS TESTED AGAIN FOR INVESTIGATION PURPOSE AND THE FOLLOWING DATA WAS PROVIDED: ALINITY S ANTI-HCV (INVESTIGATION USING SERUM (B)(6) 2024) INITIAL RESULT 2.17 S/CO, REPEATED 1.39 AND 1.28 S/CO, ALINITY S ANTI-HCV (INVESTIGATION USING PLASMA (B)(6) 2024) INITIAL RESULT 2.50 S/CO, REPEATED 2.63 AND 2.67 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440776 ↗
• MalfunctionFeb 22, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S ANTI-HCV RESULTS FOR 4 DONORS WHO HAVE A HISTORY OF NONREACTIVE ANTI-HCV RESULTS. BETWEEN (B)(6) 2024 TO (B)(6) 2024 WHILE RUNNING ON THE ALINITY S SYSTEM THE FOLLOWING DATA WAS PROVIDED BY THE CUSTOMER: (B)(6) : INITIAL RESULT = 1.65 S/CO; REPEAT RESULTS = 1.64 AND 2.57 S/CO (REAGENT LOT 53019BE00). (B)(6): INITIAL RESULT = 2.42 S/CO; REPEAT RESULTS = 2.52 AND 2.56 S/CO (REAGENT LOT 53019BE00). (B)(6): INITIAL RESULT = 2.85 S/CO; REPEAT RESULTS = 2.83 AND 2.68 S/CO (REAGENT LOT 53019BE00). (B)(6): INITIAL RESULT = 1.42 S/CO; REPEAT RESULTS = 1.48 AND 1.50 S/CO (REAGENT LOT 53019BE00). ALL 4 DONORS WERE TESTED WITH NAT TESTING AND SUPPLEMENTAL EIA TESTING AND GENERATED NONREACTIVE RESULTS FOR ALL 4 DONORS. THESE DONOR UNITS WERE REJECTED AND NOT RELEASED DUE TO THE ANTI-HCV REACTIVE RESULTS GENERATED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764178 ↗
• MalfunctionFeb 22, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S ANTI-HCV RESULTS FOR 2 DONORS WHO HAVE A HISTORY OF NONREACTIVE ANTI-HCV RESULTS. BETWEEN 03JAN2024 TO FEB2024 WHILE RUNNING ON THE ALINITY S SYSTEM THE FOLLOWING DATA WAS PROVIDED BY THE CUSTOMER: (B)(6) : INITIAL RESULT = 1.94 S/CO; REPEAT RESULTS = 1.76 AND 1.81 S/CO (REAGENT LOT 51608BE00). (B)(6) : INITIAL RESULT = 2.94 S/CO; REPEAT RESULTS = 2.94 AND 2.90 S/CO (REAGENT LOT 51608BE00). BOTH DONORS WERE TESTED WITH NAT TESTING AND SUPPLEMENTAL EIA TESTING AND GENERATED NONREACTIVE RESULTS FOR BOTH DONORS. THESE DONOR UNITS WERE REJECTED AND NOT RELEASED DUE TO THE ANTI-HCV REACTIVE RESULTS GENERATED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764177 ↗
• MalfunctionDec 30, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S ANTI-HCV ON (B)(6) 2023 AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6) WAS INITIAL REACTIVE AND REPEAT REACTIVE (NO OBJECTIVE VALUES PROVIDED.) CONFIRMATORY TESTING WITH NAT WAS PERFORMED AND THE CUSTOMER REPORTED THAT THE CONFIRMATORY RESULTS WERE NEGATIVE. CUSTOMER STATED THAT THEY HAVE SENT SAMPLE OUT TO A REFERENCE LAB. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422906 ↗
• MalfunctionOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S ANTI-HCV RESULTS ON FOUR DONORS. THE FOLLOWING RESULTS WERE PROVIDED: DATE: (B)(6) 2023; ASSAY: ANTI-HCV; SID: (B)(6); ALINITY RESULTS: = 1.31 / 1.32 / 1.38 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: ANTI-HCV; SID: (B)(6); ALINITY RESULTS: = 1.23 / 1.16 / 1.18 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: ANTI-HCV; SID: (B)(6); ALINITY RESULTS: = 1.48 / 1.57 / 1.58 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: ANTI-HCV; SID: (B)(6); ALINITY RESULTS: = 1.05 / 176.37 / 178.68 S/CO; NAT RESULT: NEGATIVE. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951692 ↗
• MalfunctionDec 19, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HCV RESULTS FOR TWO DONORS. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): DONOR 1 BLEED NUMBER 5530394908 INITIAL RESULT, ON (B)(6) 2022, WAS 2.21, REPEAT WAS 1.83 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE; BLEED NUMBER 5530395212 INITIAL RESULT, ON (B)(6) 2022, WAS 1.3, REPEATS WERE 1.42 AND 1.45 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE, SUPPLEMENTAL TESTING WITH ORTHO ASSAY WAS POSITIVE; BLEED NUMBER 5530395471 INITIAL RESULT, ON (B)(6) 2022, WAS 0.99 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE; BLEED NUMBER 5530394908 INITIAL RESULT, ON (B)(6) 2022, WAS 2.27, REPEATS WERE 1.96 AND 1.73 S/CO, NO ADDITIONAL TESTING WAS PERFORMED FOR THIS SPECIMEN. DONOR 2 BLEED NUMBER 5530394626 INITIAL RESULT, ON (B)(6) 2022, WAS 1.11, REPEATS WERE 0.99 AND 1.01 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE, SUPPLEMENTAL TESTING WITH ORTHO ASSAY WAS POSITIVE; BLEED NUMBER 5530394872 INITIAL RESULT, ON 19AUG2022, WAS 0.77, REPEAT WAS 0.73 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE; BLEED NUMBER 5530395180 INITIAL RESULT, ON (B)(6) 2022, WAS 0.71 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE. THERE WAS NO IMPACT TO D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004833 ↗
• MalfunctionJul 12, 2022False Negative Result; False Negative Result

  A NONREACTIVE ALINITY S ANTI-HCV RESULT OF 0.32 S/CO WAS GENERATED FOR AN ALINITY S ANTI-HCV II CLINICAL TRIAL DONOR RE-ENTRY SAMPLE (SID (B)(6). THE DONOR WAS PREVIOUSLY DEFERRED DURING ALINITY S ANTI-HCV II CLINICAL TRIALS. THE NONREACTIVE ALINITY S ANTI-HCV RESULT OF 0.32 S/CO IS CONSIDERED TO BE FALSE NONREACTIVE. DONOR RE-ENTRY PROCESS IS CONDUCTED FOR SAMPLES THAT WERE DISCREPANT DURING INITIAL CLINICAL TRIAL TESTING FOR THE ALINITY S ANTI-HCV II ASSAY. RE-ENTRY TESTING: (B)(6) 2022. SID (B)(6). ALINITY S ANTI-HCV RESULT: NONREACTIVE 0.32 S/CO. ALINITY S ANTI-HCV II RESULT: REPEAT REACTIVE 13.59, 13.44, 13.30 S/CO. NAT RESULT: NONREACTIVE. ORTHO RESULT: NONREACTIVE. INITIAL TESTING: (B)(6) 2021. SID (B)(6). ALINITY S ANTI-HCV RESULT: NONREACTIVE 0.26 S/CO. ALINITY S ANTI-HCV II RESULT: REPEAT REACTIVE 11.53, 12.06, 12.02 S/CO. NAT RESULT: NEGATIVE. ROCHE ANTI-HCV II RESULT: REACTIVE. NO IMPACT TO DONOR OR PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987799 ↗
• MalfunctionFeb 7, 2022False Negative Result; False Negative Result

  ALINITY S ANTI-HCV TESTING WAS PERFORMED FOR A US CLINICAL TRIAL DONOR RE-ENTRY SAMPLE, ID (B)(6), ON (B)(6) 2021. THE RESULT WAS NONREACTIVE AT (B)(6) S/CO. TESTING USING THE ALINITY S ANTI-HCV II ASSAY WAS REPEAT REACTIVE ((B)(6) AND (B)(6) S/CO). NAT WAS NEGATIVE. ORTHO ANTI-HCV TESTING WAS REPEAT REACTIVE. THIS DONOR WAS DEFERRED DURING INITIAL CLINICAL TRIAL TESTING FOR THE ALINITY S ANTI-HCV II ASSAY ON (B)(6) 2021. THE RESULTS WERE AS FOLLOWS: ALINITY S ANTI-HCV: (B)(6) S/CO NONREACTIVE. ALINITY S ANTI-HCV II: (B)(6) AND (B)(6) S/CO REPEAT REACTIVE. NAT: NEGATIVE. ROCHE ANTI-HCV: REACTIVE. DURING THE INITIAL CLINICAL TRIAL TESTING ON (B)(6) 2021, THE CORRECT RESULT FOR THE DONOR SAMPLE WAS DETERMINED TO BE REACTIVE. THE ALINITY S ANTI-HCV RESULT GENERATED ON (B)(6) 2021 IS CONSIDERED TO BE A POTENTIAL FALSE NONREACTIVE. IT IS UNKNOWN WHICH RESULT THE CUSTOMER BELIEVES IS CORRECT FOR THIS DONOR. NO IMPACT TO PATIENT OR DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13473688 ↗
• MalfunctionFeb 4, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED (B)(6) ALINITY S ANTI-HCV RESULTS ON ONE DONOR SPECIMEN WHEN COMPARE TO (B)(6) RESULTS DURING DESIGN VALIDATION AND CLINICAL STUDY PROCESSES. (B)(6). IT IS UNKNOWN WHICH RESULT THE CUSTOMER BELIEVES IS CORRECT FOR THIS DONOR. THERE WAS NO REPORTED IMAPCT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13457703 ↗
• MalfunctionFeb 2, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED POTENTIAL (B)(6) ALINITY S ANTI-HCV RESULTS ON ONE DONOR SPECIMEN WHEN COMPARE TO (B)(6) RESULTS. THAT DONOR INITIALLY DEFERRED DURING (B)(6) CLINICAL TRIALS AND TESTED AGAIN FOR RE-ENTRY. THOSE RESULTS USED FOR PATIENT MANAGEMENT AND PROVIDED WERE: INITIAL SID: (B)(6); INITIAL (B)(6) RESULT: (B)(6); INITIAL (B)(6) RESULT: (B)(6); INITIAL (B)(6) RESULT: (B)(6); INITIAL (B)(6) RESULT: (B)(6). ON (B)(6) 2022: RE-ENTRY SID: (B)(6); RE-ENTRY (B)(6) RESULT: (B)(6); RE-ENTRY (B)(6) RESULT: (B)(6) (INITIAL: (B)(6), REPEAT: (B)(6)); RE-ENTRY (B)(6) RESULT: (B)(6); RE-ENTRY (B)(6) RESULT: (B)(6). IT IS UNCLEAR WHICH RESULTS ARE CORRECT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13429609 ↗
• MalfunctionNov 1, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED (B)(6) ALINITY S ANTI-HCV RESULTS ON TWO DONORS. RESULTS PROVIDED: (B)(6) 2021 SID(B)(6), NAT = (B)(6). (B)(6) 2021, SID (B)(6) = (B)(6). NAT = (B)(6). NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726876 ↗
• MalfunctionOct 27, 2021False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HCV RESULTS FOR A PATIENT/DONOR SAMPLE WHEN REPEAT TESTING OF THE SAMPLES WERE PERFORMED DUE TO THE ORIGINAL RELEASE CONTROL FAILURES THAT WERE GENERATED ON MULTIPLE REAGENT CARTRIDGES OF THE ALINITY S ANTI- HCV ASSAY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE: < 1.00 S/CO IS NONREACTIVE, >/= 1.00 S/CO IS REACTIVE): INITIAL RESULT = 1.72 S/CO, REPEATED ON ANOTHER ANALYZER = 0.73, 0.68 S/CO WITH REAGENT CARTRIDGE SN#(B)(6), REPEATED USING A THIRD CARTRIDGE SN#(B)(6) = 1.64, 1.72 S/CO, ROCHE NAT TESTING = NEGATIVE, ORTHO ELISA HCV = NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706725 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HCV RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED NEGATIVE BY CONFIRMATORY TESTING. THE CUSTOMER PROVIDED THE FOLLOWING SUMMARY OF REPEAT REACTIVE AND CONFIRMATORY RESULTS ACROSS SEVERAL MONTHS/REAGENT LOTS. NO INDIVIDUAL PATIENT RESULTS WERE PROVIDED. (B)(6) 2021 REPEAT REACTIVE=26 / CONFIRMATORY TESTING NEGATIVE=20. (B)(6) 2021 REPEAT REACTIVE=34/ CONFIRMATORY TESTING NEGATIVE =30. (B)(6) 2021 REPEAT REACTIVE=28 / CONFIRMATORY TESTING NEGATIVE =16. (B)(6) 2021 REPEAT REACTIVE=27 / CONFIRMATORY TESTING NEGATIVE =17. (B)(6) 2021 REPEAT REACTIVE=31 / CONFIRMATORY TESTING NEGATIVE=21. (B)(6) 2021 REPEAT REACTIVE=24 / CONFIRMATORY TESTING NEGATIVE=17. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355410 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED (B)(6) REPEAT (B)(6) ALINITY S ANTI-HCV RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED (B)(6) BY CONFIRMATORY TESTING. THE RESULTS PROVIDED WERE: (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 12354449 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED (B)(6) ALINITY S ANTI-HCV RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED NEGATIVE BY CONFIRMATORY TESTING. THE RESULTS PROVIDED WERE: (B)(6). THE ALINITY S PROCESSING MODULE NOT IN TEST OF RECORD BEFORE (B)(6) 2021. THOSE DATA PROVIDED (B)(6) 2020 THROUGH (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 12354408 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED (B)(6) ALINITY S ANTI-HCV RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED (B)(6) BY CONFIRMATORY TESTING. THE RESULTS PROVIDED WERE: 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 12354258 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HCV RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED NEGATIVE BY CONFIRMATORY TESTING. THE CUSTOMER PROVIDED THE FOLLOWING SUMMARY OF REPEAT REACTIVE AND CONFIRMATORY RESULTS ACROSS SEVERAL MONTHS/REAGENT LOTS. NO INDIVIDUAL PATIENT RESULTS WERE PROVIDED. (B)(6) 2021 REPEAT REACTIVE=26 / CONFIRMATORY TESTING NEGATIVE=20. (B)(6) 2021 REPEAT REACTIVE=34/ CONFIRMATORY TESTING NEGATIVE =30. (B)(6) 2021 REPEAT REACTIVE=28 / CONFIRMATORY TESTING NEGATIVE =16. (B)(6) 2021 REPEAT REACTIVE=27 / CONFIRMATORY TESTING NEGATIVE =17. (B)(6) 2021 REPEAT REACTIVE=31 / CONFIRMATORY TESTING NEGATIVE=21. (B)(6) 2021 REPEAT REACTIVE=24 / CONFIRMATORY TESTING NEGATIVE=17. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354220 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED (B)(6) ALINITY S ANTI-HCV RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED NEGATIVE BY CONFIRMATORY TESTING. THE RESULTS PROVIDED WERE: (B)(6) 2021. 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 12354195 ↗
• MalfunctionJun 11, 2021False Negative Result; False Negative Result

  THE CUSTOMER IS PERFORMING A CLINICAL TRIAL ON THE ALINITY S ANTI-HCV II ASSAY PROCESSED ON ANOTHER ALINITY S COMPARING TO THE CURRENT ON-MARKET ALINITY S ANTI-HCV ASSAY (PROCESSED ON THIS ALINITY S. DISCREPANT RESULTS PROVIDED: (B)(6). NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986180 ↗