Alinity 06P0850Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380740117221), received between Jun 2, 2021 and Jul 2, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (23 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED IN THE MONTH OF(B)(6) 2025, THERE WERE 4 FALSE REPEAT REACTIVE RESULTS FOR ALINITY S CHAGAS OUT OF 3,131 SPECIMENS. OF THESE, 3 SPECIMENS WERE CONFIRMED AS NONREACTIVE BY ENZYME STRIP ASSAY (ESA) CONFIRMATORY TESTING. THE CUSTOMER PROVIDED THE FOLLOWING SPECIMEN SIDS FOR THE REPEAT REACTIVE RESULTS: ON (B)(6) 2025 SID (B)(6) =REPEAT REACTIVE /ESA=NONREACTIVE ON (B)(6) 2025 AND (B)(6) 2025 SID (B)(6) =REPEAT REACTIVE /ESA=NONREACTIVE ON (B)(6) 2025 SID (B)(6) =REPEAT REACTIVE /ESA=NONREACTIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386271 ↗
• MalfunctionApr 7, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED INCREASED REACTIVE RATES FOR ALINITY S CHAGAS. THE CUSTOMER FURTHER REPORTED THERE WERE SAMPLES THAT WERE REPEAT REACTIVE AND NEGATIVE BY OTHER TESTING. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SAMPLES TESTED ON LOT 67249BE00, A LOT THAT WAS CURRENTLY BEING USED: SAMPLE ID (B)(6) INITIAL RESULT WAS 1.84 (REACTIVE) AND REPEAT RESULTS WERE 1.69 (REACTIVE) & 1.71 (REACTIVE). ORTHO ESA TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) INITIAL RESULT WAS 1.98 (REACTIVE) AND REPEAT RESULTS WERE 1.99 (REACTIVE) & 1.89 (REACTIVE). ORTHO ESA TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) INITIAL RESULT WAS 1.11 (REACTIVE) AND REPEAT RESULTS WERE 1.40 (REACTIVE) & 1.37 (REACTIVE). ORTHO ESA TESTING GENERATED A NEGATIVE RESULT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21793783 ↗
• MalfunctionApr 7, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED INCREASED REACTIVE RATES FOR ALINITY S CHAGAS. THE CUSTOMER FURTHER REPORTED THERE WERE SAMPLES THAT WERE REPEAT REACTIVE AND NEGATIVE BY OTHER TESTING. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SAMPLES TESTED ON LOT 59425BE00 SAMPLE ID (B)(6) INITIAL RESULT WAS 1.77 (REACTIVE) AND REPEAT RESULTS WERE 1.79 (REACTIVE) & 1.77 (REACTIVE). ORTHO ESA TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) INITIAL RESULT WAS 1.00 (REACTIVE) AND REPEAT RESULTS WERE 1.01 (REACTIVE) & 1.04 (REACTIVE). ORTHO ESA TESTING GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED LOT 59425BE00 WAS IN USE FROM (B)(6) 2025 TO (B)(6) 2025. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21793782 ↗
• MalfunctionMar 4, 2023False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT THERE ARE AN INCREASED NUMBER INITIAL REACTIVE ALINITY S CHAGAS PATIENT SAMPLES. ONE SAMPLE HAS COME BACK INDETERMINATE FROM CONFIRMATORY TESTING. THE CUSTOMER HAS PROVIDED THE FOLLOWING DATA: (B)(6) RESULTS FROM 04FEB2023 = 2.15 REPEATED ON 05FEB2023 RESULTS = 1.91 AND 2.17 CONFIRMATORY INDETERMINATE. (B)(6) RESULTS FROM 10FEB2023 = 1.15 REPEATED ON 11FEB2023 RESULTS = 1.22 AND 1.27 CONFIRMATORY TEST INDETERMINATE. (B)(6) RESULTS FROM 13FEB2023 = 1.61 REPEATED ON 15FEB2023 RESULTS = 1.57 AND 1.59 CONFIRMATORY TEST NEGATIVE. (B)(6) RESULTS FROM 17FEB2023 = 2.28 REPEATED ON 19FEB2023 RESULTS = 2.38 AND 2.18 CONFIRMATORY TEST INDETERMINATE. (B)(6) RESULTS FROM 23FEB2023 = 1.01 REPEATED ON 24FEB2023 RESULTS = 1.05 AND 1.06 CONFIRMATORY TEST INDETERMINATE. ADDITIONAL DATA PROVIDED 16MAR2024: (B)(6) RESULTS FROM 03MAR2023 = 1.40 REPEATED ON 05MAR2023 RESULTS = 1.50 AND 1.54. (B)(6) RESULTS FROM 08MAR2023 = 1.03 REPEATED ON 10MAR2023 RESULTS = 1.03 AND 1.00. (B)(6) RESULTS FROM 09MAR2023 = 1.74 REPEATED ON 10MAR2023 RESULTS = 1.65 AND 1.62. (B)(6) RESULTS FROM 14MAR2023 = 1.37 REPEATED ON 14MAR2023 RESULTS = 1.45 AND 1.41. NO ADVERSE IMPACT TO DONOR OR PATIENT MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483459 ↗
• MalfunctionDec 21, 2022False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT THERE ARE AN INCREASED NUMBER INITIAL REACTIVE ALINITY S CHAGAS PATIENT SAMPLES. THE CUSTOMER SENT OUT SAMPLES TO CONFIRM AND RESULTS ARE SOMETIMES NONREACTIVE OR INDETERMINATE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 1.19 S/CO REACTIVE, ON (B)(6) 2022 REPEAT RESULTS = 0.91 NONREACTIVE AND 1.11 REACTIVE, CONFIRMATORY TEST(ABBOTT ESA) = NONREACTIVE. SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 1.15 S/CO REACTIVE, ON (B)(6) 2022 REPEAT RESULTS = 1.34 REACTIVE AND 1.33 REACTIVE, CONFIRMATORY TEST(ABBOTT ESA) = NONREACTIVE. SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 3.68 S/CO REACTIVE, ON (B)(6) 2022 REPEAT RESULTS = 3.66 REACTIVE AND 3.70 REACTIVE, CONFIRMATORY TEST(ABBOTT ESA) = NONREACTIVE. SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 1.12 S/CO REACTIVE, ON (B)(6) 2022 REPEAT RESULTS = 1.12 REACTIVE AND 1.11 REACTIVE, CONFIRMATORY TEST(ABBOTT ESA) = NONREACTIVE. SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 1.63 S/CO REACTIVE, ON (B)(6) 2022 REPEAT RESULTS = 1.57 REACTIVE AND 1.73 REACTIVE, CONFIRMATORY TEST(ABBOTT ESA) = INDETERMINATE. SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 1.03 S/CO REACTIVE, ON (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023760 ↗
• MalfunctionDec 21, 2022False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT THERE ARE AN INCREASED NUMBER INITIAL REACTIVE ALINITY S CHAGAS PATIENT SAMPLES. THE CUSTOMER SENT OUT SAMPLES TO CONFIRM AND RESULTS ARE SOMETIMES NONREACTIVE OR INDETERMINATE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 1.19 S/CO REACTIVE, ON (B)(6) 2022 REPEAT RESULTS = 0.91 NONREACTIVE AND 1.11 REACTIVE, CONFIRMATORY TEST(ABBOTT ESA) = NONREACTIVE. SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 1.15 S/CO REACTIVE, ON (B)(6) 2022 REPEAT RESULTS = 1.34 REACTIVE AND 1.33 REACTIVE, CONFIRMATORY TEST(ABBOTT ESA) = NONREACTIVE. SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 3.68 S/CO REACTIVE, ON (B)(6) 2022 REPEAT RESULTS = 3.66 REACTIVE AND 3.70 REACTIVE, CONFIRMATORY TEST(ABBOTT ESA) = NONREACTIVE. SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 1.12 S/CO REACTIVE, ON (B)(6) 2022 REPEAT RESULTS = 1.12 REACTIVE AND 1.11 REACTIVE, CONFIRMATORY TEST(ABBOTT ESA) = NONREACTIVE. SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 1.63 S/CO REACTIVE, ON (B)(6) 2022 REPEAT RESULTS = 1.57 REACTIVE AND 1.73 REACTIVE, CONFIRMATORY TEST(ABBOTT ESA) = INDETERMINATE. SID: (B)(6), ON (B)(6) 2022 INITIAL RESULT = 1.03 S/CO REACTIVE, ON (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023652 ↗
• MalfunctionSep 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S CHAGAS RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED NEGATIVE BY ESA CONFIRMATORY TESTING IN TWO DIFFERENT SITES RIBC AND NYBC. THE CUSTOMER PROVIDED A SUMMARY OF RESULTS ACROSS SEVERAL MONTHS AND LOT NUMBERS. NO INDIVIDUAL DONOR RESULTS WERE PROVIDED. THE NUMBER OF FALSE REPEAT REACTIVE DONORS FOR EACH MONTH WERE: RIBC: MAY2022 REPEAT REACTIVE=2 / ESA CONFIRMATORY TESTING NEGATIVE=2, NYBC: FEB2022 REPEAT REACTIVE=4 / ESA CONFIRMATORY TESTING NEGATIVE=4, APR2022 REPEAT REACTIVE=2 / ESA CONFIRMATORY TESTING NEGATIVE=2, MAY2022 REPEAT REACTIVE=1 / ESA CONFIRMATORY TESTING NEGATIVE=1 THERE WAS NO REPORTED IMPACT TO DONOR/PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396198 ↗
• MalfunctionSep 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S CHAGAS RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED NEGATIVE BY ESA CONFIRMATORY TESTING IN TWO DIFFERENT SITES RIBC AND NYBC. THE CUSTOMER PROVIDED A SUMMARY OF RESULTS ACROSS SEVERAL MONTHS AND LOT NUMBERS. NO INDIVIDUAL DONOR RESULTS WERE PROVIDED. THE NUMBER OF FALSE REPEAT REACTIVE DONORS FOR EACH MONTH WERE:RIBC: MAY2022 REPEAT REACTIVE=2 / ESA CONFIRMATORY TESTING NEGATIVE=2NYBC: FEB2022 REPEAT REACTIVE=4 / ESA CONFIRMATORY TESTING NEGATIVE=4APR2022 REPEAT REACTIVE=2 / ESA CONFIRMATORY TESTING NEGATIVE=2MAY2022 REPEAT REACTIVE=1 / ESA CONFIRMATORY TESTING NEGATIVE=1 THERE WAS NO REPORTED IMPACT TO DONOR/PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396187 ↗
• MalfunctionSep 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S CHAGAS RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED NEGATIVE BY ESA CONFIRMATORY TESTING IN TWO DIFFERENT SITES RIBC AND NYBC. THE CUSTOMER PROVIDED A SUMMARY OF RESULTS ACROSS SEVERAL MONTHS AND LOT NUMBERS. NO INDIVIDUAL DONOR RESULTS WERE PROVIDED. THE NUMBER OF FALSE REPEAT REACTIVE DONORS FOR EACH MONTH WERE: RIBC: (B)(6) 2022 REPEAT REACTIVE=2 / ESA CONFIRMATORY TESTING NEGATIVE=2. NYBC: (B)(6) 2022 REPEAT REACTIVE=4 / ESA CONFIRMATORY TESTING NEGATIVE=4. ON (B)(6) 2022 REPEAT REACTIVE=2 / ESA CONFIRMATORY TESTING NEGATIVE=2. ON (B)(6) 2022 REPEAT REACTIVE=1 / ESA CONFIRMATORY TESTING NEGATIVE=1. THERE WAS NO REPORTED IMPACT TO DONOR/PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396032 ↗
• MalfunctionApr 6, 2022False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT IN THE MONTH OF (B)(6) 2022, THERE WERE 4 REACTIVE ALINITY S CHAGAS PATIENT SAMPLES THAT WERE NEGATIVE USING THE ESA CHAGAS METHOD. WHEN THE CUSTOMER ENCOUNTERS A REACTIVE RESULT ON THE ALINITY S PROCESSING MODULE, THEY AUTOMATICALLY REPEAT THE SAMPLE AGAIN IN DUPLICATE AND IF IT REMAINS REACTIVE, THEN THEY SEND IT OUT FOR CONFIRMATION USING THE ESA CHAGAS METHOD. THE CUSTOMER INDICATED THAT OF 13 REPEATEDLY REACTIVE ALINITY S CHAGAS SAMPLES THAT WERE SENT OUT FOR CONFIRMATION, 4 OF THOSE WERE REPORTED AS CONFIRMATION NEGATIVE (ESA METHOD). NO ADVERSE IMPACT TO DONOR OR PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021806 ↗
• MalfunctionJan 11, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S CHAGAS RESULTS 12 OUT OF 31 DONOR SPECIMENS WHICH CONFIRMED NONREACTIVE BY ESA CONFIRMATORY TESTING. THE CUSTOMER PROVIDED THE FOLLOWING SUMMARY OF REPEAT REACTIVE AND CONFIRMATORY RESULTS ACROSS SEVERAL MONTHS AND REAGENT LOT NUMBER. NO INDIVIDUAL DONOR RESULTS PROVIDED OR SPECIFY THE REAGENT LOTS IN USE FOR THE SAMPLES THE SAME INFORMATION WAS REPORTED ACROSS ALL REAGENT LOTS. STARTING FROM (B)(6) 2021 ALINITY CHAGAS= REPEAT REACTIVE /CONFIRMATORY ON ESA (ENZYME STRIP ASSAY) =NONREACTIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13231301 ↗
• MalfunctionJan 11, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S CHAGAS RESULTS 12 OUT OF 31 DONOR SPECIMENS WHICH CONFIRMED NONREACTIVE BY ESA CONFIRMATORY TESTING. THE CUSTOMER PROVIDED THE FOLLOWING SUMMARY OF REPEAT REACTIVE AND CONFIRMATORY RESULTS ACROSS SEVERAL MONTHS AND REAGENT LOT NUMBER. NO INDIVIDUAL DONOR RESULTS PROVIDED OR SPECIFY THE REAGENT LOTS IN USE FOR THE SAMPLES THE SAME INFORMATION WAS REPORTED ACROSS ALL REAGENT LOTS. STARTING FROM (B)(6) 2021 ALINITY CHAGAS= REPEAT REACTIVE /CONFIRMATORY ON ESA (ENZYME STRIP ASSAY) =NONREACTIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13231262 ↗
• MalfunctionJan 11, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S CHAGAS RESULTS 12 OUT OF 31 DONOR SPECIMENS WHICH CONFIRMED NONREACTIVE BY ESA CONFIRMATORY TESTING. THE CUSTOMER PROVIDED THE FOLLOWING SUMMARY OF REPEAT REACTIVE AND CONFIRMATORY RESULTS ACROSS SEVERAL MONTHS AND REAGENT LOT NUMBER. NO INDIVIDUAL DONOR RESULTS PROVIDED OR SPECIFY THE REAGENT LOTS IN USE FOR THE SAMPLES THE SAME INFORMATION WAS REPORTED ACROSS ALL REAGENT LOTS. STARTING FROM (B)(6) 2021 ALINITY CHAGAS= REPEAT REACTIVE /CONFIRMATORY ON ESA (ENZYME STRIP ASSAY) =NONREACTIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13231044 ↗
• MalfunctionDec 21, 2021False Positive Result; False Positive Result

  THE CUSTOMER QUESTIONED REPEATEDLY REACTIVE ALINITY S CHAGAS RESULTS FOR FIVE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2021 SID (B)(6) INITIAL RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) 2021 RESULT (B)(6) S/CO (REACTIVE) AND (B)(6) S/CO (REACTIVE; FINAL ASSAY INTERPRETATION REPEATEDLY REACTIVE) REPEAT CONFIRMATION RUNS USING ANOTHER METHOD (UNKNOWN) PENDING. (B)(6) 2021 SID (B)(6) INITIAL RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) 2021 RESULT (B)(6) S/CO (REACTIVE) AND (B)(6) S/CO (REACTIVE; FINAL ASSAY INTERPRETATION REPEATEDLY REACTIVE) REPEAT CONFIRMATION RUNS USING ANOTHER METHOD (UNKNOWN) NEGATIVE. (B)(6) 2021 SID (B)(6) INITIAL RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) 2021 RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) S/CO (REACTIVE; FINAL ASSAY INTERPRETATION REPEATEDLY REACTIVE) REPEAT CONFIRMATION RUNS USING ANOTHER METHOD (UNKNOWN) PENDING. (B)(6) 2021 SID (B)(6) INITIAL RESULT (B)(6) S/CO (REACTIVE), REPEATED (B)(6) 2021 RESULT (B)(6) S/CO (REACTIVE) AND (B)(6) S/CO (REACTIVE; FINAL ASSAY INTERPRETATION REPEATEDLY REACTIVE) REPEAT CONFIRMATION RUNS USING ANOTHER METHOD (UNKNOWN) POSITIVE. (B)(6) 2021 SID (B)(6) INITIAL RESULT (B)(6) S/CO (REACTIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056283 ↗
• MalfunctionDec 10, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S CHAGAS RESULTS 12 OUT OF 31 DONOR SPECIMENS WHICH CONFIRMED NONREACTIVE BY ESA CONFIRMATORY TESTING. THE CUSTOMER PROVIDED THE FOLLOWING SUMMARY OF REPEAT REACTIVE AND CONFIRMATORY RESULTS ACROSS SEVERAL MONTHS AND REAGENT LOT NUMBER. NO INDIVIDUAL DONOR RESULTS PROVIDED OR SPECIFY THE REAGENT LOTS IN USE FOR THE SAMPLES THE SAME INFORMATION WAS REPORTED ACROSS ALL REAGENT LOTS. STARTING FROM (B)(6) 2021 ALINITY CHAGAS= REPEAT REACTIVE /CONFIRMATORY ON ESA (ENZYME STRIP ASSAY) = NONREACTIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12979641 ↗
• MalfunctionNov 3, 2021False Positive Result; False Positive Result

  THE ACCOUNT GENERATED REPEAT REACTIVE ALINITY S CHAGAS RESULTS ON SAMPLES THAT REPEATED INDETERMINATE OR NEGATIVE WITH CONFIRMATORY TESTING IN (B)(6) 2021. SID: (B)(6) TESTED CONFIRMATORY INDETERMINATE. SID: (B)(6) TESTED CONFIRMATORY INDETERMINATE . SID: (B)(6) TESTED CONFIRMATORY NEGATIVE . SID: (B)(6) TESTED CONFIRMATORY INDETERMINATE. (B)(6) 2021 DATA SHOWED ALINITY S CHAGAS REPEAT REACTIVE SAMPLES WITH CONFIRMATORY. CHAGAS (CESA) NEGATIVE OR INDETERMINATE. SID (B)(6) TESTED CONFIRMATORY NEGATIVE. SID (B)(6) TESTED CONFIRMATORY INDETERMINATE. SID (B)(6) TESTED CONFIRMATORY INDETERMINATE. SID (B)(6) TESTED CONFIRMATORY INDETERMINATE. NO SPECIFIC DONOR INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12747686 ↗
• MalfunctionOct 7, 2021False Positive Result; False Positive Result

  ADDITIONAL INFORMATION WAS PROVIDED. OCTOBER 2021 DATA SHOWED REPEAT REACTIVE ALINITY S CHAGAS RESULTS ON SAMPLES WITH CONFIRMATORY TESTING FOR SIDS (B)(6) WAS INDETERMINATE. CONFIRMATORY TESTING FOR SIDS (B)(6) WAS NEGATIVE. NO SPECIFIC DONOR INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595072 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S CHAGAS RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED NEGATIVE BY ESA 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 JUL2020 THROUGH DEC2020 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 12353645 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S CHAGAS RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED NEGATIVE BY ESA CONFIRMATORY TESTING. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 REPEAT REACTIVE=4 / ESA CONFIRMATORY TESTING NEGATIVE=1. ON (B)(6) 2021 REPEAT REACTIVE=2 /ESA CONFIRMATORY TESTING NEGATIVE =1. ON (B)(6) 2021 REPEAT REACTIVE=3 / ESA CONFIRMATORY TESTING NEGATIVE=3. ON (B)(6) 2021 REPEAT REACTIVE=3/ ESA CONFIRMATORY TESTING NEGATIVE=1. 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 12353542 ↗
• MalfunctionAug 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S CHAGAS RESULTS ON MULTIPLE DONOR SPECIMENS WHICH CONFIRMED NEGATIVE BY ESA CONFIRMATORY TESTING. THE RESULTS PROVIDED WERE: JAN2021 REPEAT REACTIVE=4 / ESA CONFIRMATORY TESTING NEGATIVE=1. MAR2021 REPEAT REACTIVE=2 /ESA CONFIRMATORY TESTING NEGATIVE =1. MAY2021 REPEAT REACTIVE=3 / ESA CONFIRMATORY TESTING NEGATIVE=3. JUN2021 REPEAT REACTIVE=3/ ESA CONFIRMATORY TESTING NEGATIVE=1. THE ALINITY S PROCESSING MODULE NOT IN TEST OF RECORD BEFORE JAN2021. THOSE DATA PROVIDED JUL2020 THROUGH DEC2020 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 12353483 ↗
• MalfunctionAug 12, 2021False Positive Result; False Positive Result

  THE ACCOUNT OBSERVED INCREASED REPEAT REACTIVE RATES WHILE USING ALINITY S CHAGAS (LOTS 16211BE00, 23029BE00, AND 25291BE00 AND ALINITY S PROCESSING MODULE SERIALS (B)(4), SERIAL (B)(4)). SUPPLEMENTAL ESA TESTING PERFORMED IDENTIFIED MULTIPLE SAMPLES DISCREPANT TO ALINITY S CHAGAS. THERE WAS NO ADDITIONAL PATIENT/DONOR INFORMATION PROVIDED BY THE CUSTOMER DUE TO PRIVACY ISSUES. THERE WAS NO REPORTED IMPACT TO DONOR/PATIENT MANAGEMENT. THE CUSTOMER REPORTED AN INCREASE IN REPEAT REACTIVE (RR) ALINITY S CHAGAS RESULTS. THE RESULTS PROVIDED WERE THE FOLLOWING: ON (B)(6) 2021 SID (B)(6) =2.03, 2.00, 1.99S/CO (>/=1.00S/CO = REACTIVE) / CONFIRMATORY CESA = NONREACTIVE. ON (B)(6) SID (B)(6) = 2.14, 2.06, 2.00S/CO / CONFIRMATORY CESA = INDETERMINATE (GRAYZONE). ON (B)(6) SID (B)(6) =1.46, 1.03, 1.35S/CO / CONFIRMATORY CESA = INDT (GRAYZONE). ON (B)(6) SID (B)(6) = 1.29, 1.41, 1.44S/CO / CONFIRMATORY CESA = INDT (GRAYZONE). ON (B)(6) SID (B)(6) = 1.04, 1.02, 1.07S/CO / CONFIRMATORY CESA = NONREACTIVE. EARLY (B)(6) 2021 RESULTS ARE: (B)(6) SID (B)(6) = 2.05, 2.17, 2.16S/CO / CESA CONFIRMATORY NEGATIVE. ON (B)(6) SID (B)(6) = 2.21, 2.31, 2.34S/CO / CESA CONFIRMATORY NEGATIVE. ON (B)(6) SID (B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314398 ↗
• MalfunctionJun 2, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN INCREASE IN REPEAT REACTIVE (RR) ALINITY S CHAGAS RESULTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6)=2.03, 2.00, 1.99S/CO (>/=1.00S/CO = REACTIVE) / CONFIRMATORY CESA = NONREACTIVE / ON 13APR SID (B)(6)= 2.14, 2.06, 2.00S/CO / CONFIRMATORY CESA = INDETERMINATE (GRAYZONE); ON 16APR SID (B)(6)=1.46, 1.03, 1.35S/CO / CONFIRMATORY CESA = INDT (GRAYZONE); ON 16APR (B)(6)= 1.29, 1.41, 1.44S/CO / CONFIRMATORY CESA = INDT (GRAYZONE); ON 28APR SID (B)(6) = 1.04, 1.02, 1.07S/CO / CONFIRMATORY CESA = NONREACTIVE. EARLY MAY 2021 RESULTS ARE: 01MAY AND 02MAY SID (B)(6)= 2.05, 2.17, 2.16S/CO; 04, 05, 06MAY SID (B)(6) = 2.21, 2.31, 2.34S/CO; 09 AND 10MAY SID(B)(6) = 1.28, 1.33, 1.38S/CO; 12MAY SID (B)(6) = 7.89, 7.88, 7.38S/CO. ON 28MAY2021 SID (B)(6) = 1.18 / RETEST ON 29MAY = 1.35 AND 1.33S/CO. ON 09JUN2021 THE MONTH OF MAY SHOWED 5 RR SAMPLES: ON 02MAY SID (B)(6) RR / CONFIRMATORY NEGATIVE; ON 06MAY SID (B)(6) RR / CONFIRMATORY = NEGATIVE; ON 10MAY SID (B)(6) RR / CONFIRMATORY INDT; ON 14MAY SID (B)(6) / CONFIRMATORY INDT; ON 31MAY SID (B)(6)RR / CONFIRMATORY NEGATIVE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921052 ↗
• MalfunctionJun 2, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN INCREASE IN REPEAT REACTIVE (RR) ALINITY S CHAGAS RESULTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) =2.03, 2.00, 1.99S/CO (>/=1.00S/CO = REACTIVE) / CONFIRMATORY CESA = NONREACTIVE / ON (B)(6) 2021 SID (B)(6)= 2.14, 2.06, 2.00S/CO / CONFIRMATORY CESA = INDETERMINATE (GRAYZONE); ON (B)(6) 2021 SID (B)(6)=1.46, 1.03, 1.35S/CO / CONFIRMATORY CESA = INDT (GRAYZONE); ON (B)(6) 2021 SID (B)(6) = 1.29, 1.41, 1.44S/CO / CONFIRMATORY CESA = INDT (GRAYZONE); ON (B)(6) 2021 SID (B)(6) = 1.04, 1.02, 1.07S/CO / CONFIRMATORY CESA = NONREACTIVE. EARLY (B)(6) 2021 RESULTS ARE: (B)(6) 2021 SID (B)(6) = 2.05, 2.17, 2.16S/CO; 04, 05, (B)(6) 2021 SID (B)(6) = 2.21, 2.31, 2.34S/CO; 09 AND (B)(6) 2021 SID (B)(6) = 1.28, 1.33, 1.38S/CO; (B)(6) 2021 SID (B)(6) = 7.89, 7.88, 7.38S/CO. ON (B)(6) 2021 SID (B)(6) = 1.18 / RETEST ON (B)(6) 2021 = 1.35 AND 1.33S/CO. ON (B)(6) 2021 THE MONTH OF MAY SHOWED 5 RR SAMPLES: ON (B)(6) 2021 SID (B)(6) RR / CONFIRMATORY NEGATIVE; ON (B)(6) 2021 SID (B)(6) RR / CONFIRMATORY = NEGATIVE; ON (B)(6) 2021 SID (B)(6) RR / CONFIRMATORY INDT; ON (B)(6) 2021 SID (B)(6) RR / CONFIRMATORY INDT; ON (B)(6) 2021 SID (B)(6) RR / CONFIRMATORY NEGATIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921012 ↗