Alinity 06P0160Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00380740117184), received between Dec 28, 2020 and Feb 17, 2026 — classified as 19 injuries, 34 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (53 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HIV AG/AB COMBO RESULTS, SINCE STARTING USING REAGENT LOT 77548BE00 ON THE ALINITY S SYSTEM. THE CUSTOMER STATED SAMPLES IN QUESTION WERE SENT FOR CONFIRMATORY TESTING AND THE RESULTS CAME BACK NONREACTIVE USING THE GEENIUS HIV-1/2 SUPPLEMENTAL ASSAY. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 1.00 S/CO NONREACTIVE, >/= 1.00 S/CO REACTIVE): ON (B)(6) 2026: (B)(4): INITIAL RESULT = 1.32 S/CO; REPEAT RESULT = 1.31 AND 1.34 S/CO. ON (B)(6) 2026: (B)(4): INITIAL RESULT = 1.05 S/CO; REPEAT RESULT = 1.00 AND 1.01 S/CO. (B)(4): INITIAL RESULT = 2.29 S/CO; REPEAT RESULTS = 2.36 AND 2.40 S/CO. ON (B)(6) 2026: (B)(4): INITIAL RESULT = 1.16 S/CO; REPAT RESULT = 1.00 S/CO. ON (B)(6) 2026: (B)(4): INITIAL RESULT = 2.23 S/CO; REPEAT RESULT = 2.14 AND 1.89 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370331 ↗
• MalfunctionNov 3, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, (B)(6) 2025 SID (B)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 259.76 / 243.47 / 231.68 / 230.5 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 240.04 / 227.62 / 236.70 / 281 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 364.89 / 300.76 / 285.35 / 372.4 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE. SID (B)(6) = 7.23 / 5.09 / 5.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = REPEAT REACTIVE, REPEAT RESULT = 35 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 45.50 / 45.75 / 49.93 / 0.11 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 5.72 / 1.75 / 6.15 / 0.07 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 5.14 / 6.16 / 8.69 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449114 ↗
• 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 23448962 ↗
• MalfunctionNov 3, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(60 2025 SID (B)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, (B)(6) 2025 SID (B)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 259.76 / 243.47 / 231.68 / 230.5 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 240.04 / 227.62 / 236.70 / 281 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 364.89 / 300.76 / 285.35 / 372.4 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID(B)(6) = 7.23 / 5.09 / 5.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = REPEAT REACTIVE, REPEAT RESULT = 35 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 45.50 / 45.75 / 49.93 / 0.11 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 5.72 / 1.75 / 6.15 / 0.07 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 5.14 / 6.16 / 8.69 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448806 ↗
• MalfunctionJan 23, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS FOR TWO DONORS, WHICH WERE NOT CONSISTENT WITH THE DONORS¿ PREVIOUS RESULTS. IN ADDITION, BOTH DONORS WERE NAT NEGATIVE (COBAS 800). THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): SID (B)(6): ON (B)(6) 2025 INITIAL RESULT = 9.29 S/CO (LOT 65260BE00). ON (B)(6) 2025 REPEAT RESULTS = 8.95 S/CO (LOT 65260BE00), 7.62 S/CO (LOT 65260BE00), 6.07 S/CO (LOT 63242BE00). NAT TESTING (COBAS 800) = NEGATIVE. HISTORICAL RESULTS = NEGATIVE. SID (B)(6): ON (B)(6) 2025 INITIAL RESULT = 1.79 S/CO (LOT 65260BE00). ON (B)(6) 2025 REPEAT RESULTS = 2.06 S/CO (LOT 65260BE00), 1.89 S/CO (LOT 65260BE00), 0.82 S/CO (LOT 63242BE00). NAT TESTING (COBAS 800) = NEGATIVE HISTORICAL RESULTS = NEGATIVE THERE WAS NO IMPACT TO DONOR MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218679 ↗
• MalfunctionJan 23, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS FOR A DONOR, WHICH WERE NOT CONSISTENT WITH THE DONOR'S PREVIOUS RESULTS. IN ADDITION, THE DONOR WAS NAT NEGATIVE (COBAS 800). THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): SID (B)(6): ON (B)(6) 2025 INITIAL RESULT = 9.29 S/CO (LOT 65260BE00). ON (B)(6) 2025 REPEAT RESULTS = 8.95 S/CO (LOT 65260BE00), 7.62 S/CO (LOT 65260BE00), 6.07 S/CO (LOT 63242BE00). NAT TESTING (COBAS 800) = NEGATIVE. HISTORICAL RESULTS = NEGATIVE. THERE WAS NO IMPACT TO DONOR MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218678 ↗
• MalfunctionMay 20, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB FOR ONE CADAVERIC SAMPLE. TISSUE WAS DISCARDED. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = S/CO): E00000141 HIV INITIAL RESULT = 1.5 REPEAT RESULTS = 29.49 AND 40.12 SAMPLE IS GROSSLY HEMOLYZED WITH VISIBLE PARTICULATES PRESENT GRIFOLS PROCLEIX NAT WAS NONREACTIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353847 ↗
• MalfunctionFeb 12, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HIV AG/AB COMBO RESULTS FOR A 16-YEAR-OLD FEMALE DONOR. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2023, WAS 1.99, REPEAT RESULTS WERE 1.32 AND 1.34 S/CO. THE SAMPLE WAS CONFIRMED POSITIVE ON THE GEENUIS PLATFORM ON (B)(6) 2023. THE SAMPLE WAS NEGATIVE WITH HIVNT. THE SAMPLE WAS SENT OUT FOR TESTING ON THE GRIFOLS PLATFORM AND THE HIVNT WAS NEGATIVE AND THE GEENIUS TESTING WAS WEAK AND RESULTED AS HIV-1 POSITIVE (HIV-1AB REACTIVE/HIV-2 INDETERMINATE). THE WESTERN BLOT RESULTS SHOWED GP36, GP160, AND P24 ABSENT BUT GP140, P31, GP41, AND CTRL WERE PRESENT. THE DONOR WAS REDRAWN ON (B)(6) 2024, UNDER SAMPLE ID (B)(6), INITIAL RESULT, TESTED ON (B)(6) 2024, WAS 1.04, REPEAT RESULTS WERE 0.97 AND 0.96 S/CO. THE NAT WAS NEGATIVE. THERE WAS NO IMPACT TO PATIENT OR DONOR MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686675 ↗
• InjuryOct 24, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV RESULTS FOR CADAVERIC TISSUE DONOR SAMPLES THAT WAS CONFIRMATORY NEGATIVE. THE RESULTS PROVIDED WERE:SID (B)(6) HIV=REPEAT REACTIVE (NO ACTUAL RESULTS PROVIDED) /NAT=NEGATIVE; BIORAD HIV 1,2 PLUS O ANTIBODY AS CONFIRMATION=NEGATIVE THE TISSUE WAS DISCARDED FOR IMPACTED SIDS. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995172 ↗
• InjuryOct 24, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV RESULTS FOR CADAVERIC TISSUE DONOR SAMPLES THAT WAS CONFIRMATORY NEGATIVE. THE RESULTS PROVIDED WERE: SID (B)(6) OLD FEMALE: HIV=REPEAT REACTIVE (NO ACTUAL RESULTS PROVIDED) /NAT=NEGATIVE; BIORAD HIV 1,2 PLUS O ANTIBODY AS CONFIRMATION=NEGATIVE. THE TISSUE WAS DISCARDED FOR IMPACTED SIDS. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995080 ↗
• MalfunctionOct 19, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HIV AG/AB RESULTS FOR THREE DONOR SAMPLES FROM (B)(6)2023 TO (B)(6)2023. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6)(CADAVERIC SAMPLE FROM A DONOR WITH NO HISTORY OF INFECTION): INITIAL RESULT = 2.33 S/CO, REPEATS = 1.39 S/CO AND 1.34 S/CO, REPEAT AFTER FREEZE/THAW AND 2ND CENTRIFUGATION = 0.08 S/CO, THE SAMPLE WAS SENT TO AN EXTERNAL LAB (VRL AND CORE) = NONREACTIVE, NAT = NON-REACTIVE SID (B)(6)(CADAVERIC SAMPLE FROM A DONOR WITH NO HISTORY OF INFECTION): INITIAL RESULT = 21.10 S/CO, REPEATS = 13.17 S/CO AND 13.37 S/CO, REPEAT AFTER FREEZE/THAW AND 2ND CENTRIFUGATION = 0.08 S/CO, THE SAMPLE WAS SENT TO AN EXTERNAL LAB (VRL AND CORE) = NON-REACTIVE, NAT = NONREACTIVE SID (B)(6) (PRE-MORTEM DONATION SAMPLE FROM A DONOR WITH NO HISTORY OF INFECTION): INITIAL REACTIVE = 3.40 S/CO, REPEATS = 3.30 S/CO AND 3.12 S/CO, REPEAT AFTER FREEZE/THAW AND 2ND CENTRIFUGATION = 0.08 S/CO, NAT = NONREACTIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATED CLARIFYING INFORMATION WAS PROVIDED: CADAVERIC VALIDATION SAMPLES: BOTH CADAVERIC VALIDATION SAMPLES (SID (B)(6)AND SID (B)(6)) HAD TWO TUBES DRAWN EACH. ONE TUBE WAS SENT TO VRL LABORATORY (EXTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967572 ↗
• MalfunctionOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON FIVE DONORS. THE FOLLOWING RESULTS WERE PROVIDED: DATE: (B)(6) 2023; ASSAY: HIV AG/AB; SID: (B)(6); ALINITY RESULTS: = 1.19 / 1.11 / 1.06 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HIV AG/AB; SID: (B)(6); ALINITY RESULTS: = 1.78 / 1.14 / 1.28 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HIV AG/AB; (SID: B)(6); ALINITY RESULTS: = 1.53 / 1.36 / 1.38 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HIV AG/AB; SID: (B)(6); ALINITY RESULTS: = 1.75 / 1.73 / 1.70 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HIV AG/AB; SID: (B)(6); ALINITY RESULTS: = 6.02 / 5.64 / 5.68 S/CO; NAT RESULT: NEGATIVE. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950273 ↗
• MalfunctionAug 7, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULT ON A DONOR. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2023 SID (B)(6)= 1.20 / 1.23 / 1.33 S/CO; THE CONFIRMATORY TEST WAS NEGATIVE (HIV GEENIUS). A NEW SAMPLE SID (B)(6) WAS NEGATIVE ON THE ALINITY ON (B)(6) 2023 = 0.96 S/CO. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469844 ↗
• MalfunctionMay 8, 2023False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT ALINITY S HIV AG/AB COMBO RESULTS OF 3.36 S/CO (REACTIVE), 8.58 S/CO (REACTIVE) AND 0.06 S/CO (NONREACTIVE) WERE GENERATED FOR A PATIENT (SAMPLE ID (B)(6) ) ON (B)(6) 2023. WESTERN BLOT TESTING WAS NEGATIVE FOR HIV I/II. NO IMPACT TO PATIENT/DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887964 ↗
• MalfunctionApr 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT ALINITY S HIV AG/AB COMBO RESULTS OF 1.62 S/CO (REACTIVE), 0.08 S/CO (NONREACTIVE) AND 5.66 S/CO (REACTIVE) WERE GENERATED FOR A PATIENT (SAMPLE ID (B)(6)) ON (B)(6) 2023. WESTERN BLOT TESTING WAS NEGATIVE FOR HIV I/II. NO IMPACT TO PATIENT/DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755733 ↗
• MalfunctionApr 14, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN INCREASE IN INITIAL REACTIVE AND REPEAT REACTIVE RESULTS WHEN USING THE ALINITY S HIV AG/AB COMBO ASSAY FOR THE MONTH OF MARCH 2023. THE FOLLOWING SID AND REAGENT LOT NUMBER AFFECTED THAT GENERATED REPEAT REACTIVE RESULTS ON THE ALINITY S SYSTEM, BUT TESTED NEGATIVE ON THE CUSTOMER¿S CONFIRMATORY BIO-RAD GEENIUS HIV 1 / 2 ASSAY (ACTUAL VALUES WERE NOT PROVIDED). LOT 45152BE00, W045023012926. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747130 ↗
• MalfunctionApr 14, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN INCREASE IN INITIAL REACTIVE AND REPEAT REACTIVE RESULTS WHEN USING THE ALINITY S HIV AG/AB COMBO ASSAY FOR THE MONTH OF MARCH 2023. THE FOLLOWING SIDS AND REAGENT LOT NUMBER AFFECTED THAT GENERATED REPEAT REACTIVE RESULTS ON THE ALINITY S SYSTEM BUT TESTED NEGATIVE ON THE CUSTOMER¿S CONFIRMATORY BIO-RAD GEENIUS HIV 1 / 2 ASSAY (ACTUAL VALUES WERE NOT PROVIDED): LOT 46383BE00: W045023022651, W036923300542, W121023001931, W280323110314, W045023028801, W045023022745, W089223000404, W141823000526, W051523506592,W087923302890 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747126 ↗
• MalfunctionMar 21, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS WHICH NONREACTIVE BY THE WESTERN BLOT HIV1 AND HIV2 ON MULTIPLE DONORS ON MULTIPLE ALINITY S ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2022. (B)(6). ON AS1285. INITIAL=1.00 S/CO (> OR = 1.00 S/CO=REACTIVE) /REPEATED ON (B)(6) 2022=4.25 S/CO AND 10.51 S/CO. ON (B)(6) 2022 .(B)(6). ON ALINITY AS1319 .INITIAL=2.94 S/CO /REPEATED ON (B)(6) 2022=3.84 AND 0.07 S/CO (< 1.00 S/CO=NONREACTIVE). ON (B)(6) 2022. (B)(6). ON ALI01319. INITIAL=2.86 S/CO /REPEATED=4.48 S/CO AND 0.05 S/CO. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2023: ON (B)(6) 2023. (B)(6). ON ALINITY AS1322 INITIAL=11.59 S/CO /REPEATED=9.61 S/CO AND 0.06 S/CO ADDITIONAL INFORMATION PROVIDED ON (B)(6)2023: ON (B)(6) 2023 (B)(6) ON AS1305. INITIAL=2.93 S/CO /REPEATED=8.41 S/CO AND 0.06 S/CO ON (B)(6) 2023 (B)(6) ON AS1307. INITIAL=9.56 S/CO /REPEATED=4.34 S/CO AND 0.27 S/CO ON (B)(6) 2023 (B)(6) ON AS1304 .INITIAL=1.72 S/CO /REPEATED=6.28 S/CO AND 2.98 S/CO ADDITIONAL INFORMATION PROVIDED ON 16FEB2023: ON (B)(6) 2023 (B)(6) ON AS1322. INITIAL=11.59 S/CO /REPEATED=9.61 S/CO AND 0.06 S/CO ON (B)(6) 2023 (B)(6). ON AS1305 INITIAL=2.93 S/CO /REPEATED=

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582883 ↗
• MalfunctionMar 2, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS WHICH NONREACTIVE BY THE WESTERN BLOT HIV1 AND HIV2 ON MULTIPLE DONORS ON MULTIPLE ALINITY S ANALYZER. THE RESULTS PROVIDED WERE:ON 12DEC2022 SID (B)(6) ON AS1285 INITIAL=1.00 S/CO (> OR = 1.00 S/CO=REACTIVE) /REPEATED ON 13DEC2022=4.25 S/CO AND 10.51 S/COON 15DEC2022 SID (B)(6) ON ALINITY AS1319 INITIAL=2.94 S/CO /REPEATED ON 16DEC2022=3.84 AND 0.07 S/CO (< 1.00 S/CO=NONREACTIVE)ON 16DEC2022 SID (B)(6) ON ALI01319 INITIAL=2.86 S/CO /REPEATED=4.48 S/CO AND 0.05 S/COADDITIONAL INFORMATION PROVIDED ON 10FEB2023:ON 19JAN2023 SID (B)(6) ON ALINITY AS1322 INITIAL=11.59 S/CO /REPEATED=9.61 S/CO AND 0.06 S/CO.ADDITIONAL INFORMATION PROVIDED ON 10FEB2023:ON 23JAN2023 SID (B)(6) ON AS1305 INITIAL=2.93 S/CO /REPEATED=8.41 S/CO AND 0.06 S/CO.ON 27JAN2023 SID (B)(6) ON AS1307 INITIAL=9.56 S/CO /REPEATED=4.34 S/CO AND 0.27 S/CO.ON 26JAN2023 SID (B)(6) ON AS1304 INITIAL=1.72 S/CO /REPEATED=6.28 S/CO AND 2.98 S/CO.ADDITIONAL INFORMATION PROVIDED ON 16FEB2023: ON 19JAN2023 SID (B)(6) ON AS1322 INITIAL=11.59 S/CO /REPEATED=9.61 S/CO AND 0.06 S/CO.ON 23JAN2023 SID (B)(6) ON AS1305 INITIAL=2.93 S/CO /REPEATED=8.41 S/CO AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469403 ↗
• MalfunctionJan 16, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS WHICH NONREACTIVE BY THE WESTERN BLOT HIV1 AND HIV2 ON MULTIPLE DONORS ON MULTIPLE ALINITY S ANALYZER. THE RESULTS PROVIDED WERE: ON 12DEC2022 SID (B)(6) ON (B)(4) INITIAL=1.00 S/CO (> OR = 1.00 S/CO=REACTIVE) /REPEATED ON 13DEC2022=4.25 S/CO AND 10.51 S/CO ON 15DEC2022 SID (B)(6) ON ALINITY (B)(4) INITIAL=2.94 S/CO /REPEATED ON 16DEC2022=3.84 AND 0.07 S/CO (< 1.00 S/CO=NONREACTIVE) ON 16DEC2022 SID (B)(6) ON (B)(4) INITIAL=2.86 S/CO /REPEATED=4.48 S/CO AND 0.05 S/CO ADDITIONAL INFORMATION PROVIDED ON 10FEB2023: ON 19JAN2023 SID (B)(6) ON ALINITY (B)(4) INITIAL=11.59 S/CO /REPEATED=9.61 S/CO AND 0.06 S/CO THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16173606 ↗
• InjuryDec 16, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HIV AG/AB RESULTS FOR ONE CADAVERIC TISSUE DONOR THAT WAS NAT NEGATIVE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022, SID (B)(6), INITIAL RESULT = 4.75 S/CO, REPEATS = 1.08 S/CO AND 0.94 S/CO, HEMOLYSIS = 100 MG/DL TO 250 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 15996608 ↗
• MalfunctionNov 11, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS FOR ONE SAMPLE FROM A 42-YEAR-OLD FEMALE DONOR PATIENT. SID (B)(6) GENERATED AN INITIAL RESULT OF 1.82 S/CO, REPEATED 1.73 S/CO AND 1.82 S/CO, SAMPLE WAS NORMAL IN APPEARANCE, NO HEMOLYSIS OR LIPEMIA. THE SAMPLE WAS NAT NEGATIVE. SAMPLE SENT FOR WESTERN BLOT BY THIRD PARTY, RESULTS NOT AVAILABLE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780756 ↗
• InjuryOct 25, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB RESULTS FOR MULTIPLE CADAVERIC SAMPLES. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = S/CO): (B)(6) 2022: SID: (B)(6). (SERIAL (B)(4) , LOT 34376BE00) INITIAL RESULT = 2.96, REPEATS = 5.37 AND 3.34. (B)(6) 2022: SID: (B)(6). (SERIAL (B)(4) , LOT 34376BE00) INITIAL RESULT = 2.03, REPEATS = 6.01 AND 2.90. (B)(6) 2022: SID: (B)(6). (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 3.52, REPEATS = 9.78 AND 7.32. (B)(6) 2022: SID: (B)(6). (SERIAL (B)(4) , LOT 34376BE00) INITIAL RESULT = 27.79, REPEATS = 6.12 AND 3.89. (B)(6) 2022: SID: (B)(6). (SERIAL (B)(4) , LOT 34376BE00) INITIAL RESULT = 6.67, REPEATS = 5.51 AND 3.77 (B)(6) 2022: SID: (B)(6). (SERIAL (B)(4) , LOT 34376BE00) INITIAL RESULT = 1.07, REPEATS = 1.18 AND 1.55. (B)(6) 2022: SID: (B)(6). (SERIAL (B)(4) , LOT 34376BE00) INITIAL RESULT = 1.74, REPEATS = 3.39 AND 2.26. (B)(6) 2022: SID: (B)(6). (SERIAL (B)(4) , LOT 34376BE00) INITIAL RESULT = 3.52, REPEATS = 3.41 AND 4.84. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON 13OCT2022: THE ASSOCIATED TISSUES WERE ALL DISCARDED AS IT IS LABORATORY POLICY TO DISCARD ANY TISSUE WITH REPEAT REACTIVE RESULTS. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666777 ↗
• InjuryOct 25, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB RESULTS FOR MULTIPLE CADAVERIC SAMPLES. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = S/CO): (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 2.96, REPEATS = 5.37 AND 3.34. (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 2.03, REPEATS = 6.01 AND 2.90. (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 3.52, REPEATS = 9.78 AND 7.32. (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 27.79, REPEATS = 6.12 AND 3.89. (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 6.67, REPEATS = 5.51 AND 3.77. (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 1.07, REPEATS = 1.18 AND 1.55. (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 1.74, REPEATS = 3.39 AND 2.26. (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 3.52, REPEATS = 3.41 AND 4.84. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON (B)(6) 2022: THE ASSOCIATED TISSUES WERE ALL DISCARDED AS IT IS LABORATORY POLICY TO DISCARD ANY TISSUE WITH REPEAT REACTIVE RESULTS. THE TESTING ISSUES ARE RELATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666730 ↗
• InjuryOct 25, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB RESULTS FOR MULTIPLE CADAVERIC SAMPLES. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = S/CO): (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 2.96, REPEATS = 5.37 AND 3.34, (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 2.03, REPEATS = 6.01 AND 2.90 , (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 3.52, REPEATS = 9.78 AND 7.32 , (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 27.79, REPEATS = 6.12 AND 3.89, (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 6.67, REPEATS = 5.51 AND 3.77 (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 1.07, REPEATS = 1.18 AND 1.55 (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 1.74, REPEATS = 3.39 AND 2.26 (B)(6) 2022 SID (B)(6) (SERIAL (B)(4), LOT 34376BE00) INITIAL RESULT = 3.52, REPEATS = 3.41 AND 4.84 ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON (B)(6) 2022: THE ASSOCIATED TISSUES WERE ALL DISCARDED AS IT IS LABORATORY POLICY TO DISCARD ANY TISSUE WITH REPEAT REACTIVE RESULTS. THE TESTING ISSUES ARE RELATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666725 ↗