Alinity 06P0359Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740136789), received between Oct 6, 2022 and Mar 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG AND ALINITY S HBSAG CONFIRMATORY RESULTS GENERATED FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE >/= 1.0 S/CO IS REACTIVE): UNIT OF MEASURE = S/CO SAMPLE ID (B)(6) INITIAL RESULT ON AS1453 = 3.6, REPEAT RESULTS ON (B)(6) = 2.4, 2.31; SAMPLE ID (B)(6) INITIAL RESULT ON AS1473 = 3, REPEAT RESULTS ON (B)(6) = 2.56, 2.07; SAMPLE ID (B)(6) INITIAL RESULT ON AS1473 = 4.49, REPEAT RESULTS ON (B)(6) = 4.36, 4.72; SAMPLE ID (B)(6) INITIAL RESULT ON AS1473 = 2.84, REPEAT RESULTS ON (B)(6) = 2.56, 2.81; SAMPLE ID (B)(6) INITIAL RESULT ON AS1453 = 2.09, REPEAT RESULTS ON (B)(6) = 1.39, 1.35; SAMPLE ID (B)(6) INITIAL RESULT ON AS1473 = 2.99, REPEAT RESULTS ON (B)(6) = 2.71, 2.45; SAMPLE ID (B)(6) INITIAL RESULT ON AS1486 = 1.53, REPEAT RESULTS ON (B)(6) = 1.36, 1.27; SAMPLE ID (B)(6) INITIAL RESULT ON AS1486 = 1.37, REPEAT RESULTS ON (B)(6) = 1.09, 1.16; SAMPLE ID (B)(6) INITIAL RESULT ON AS1453 = 6.15, REPEAT RESULTS ON (B)(6) = 2.95, 2.93; SAMPLE ID (B)(6) INITIAL RESULT ON AS1453 = 20.97, REPEAT RESULTS ON (B)(6) = 12, 12.35; SAMPLE ID(B)(6) INITIAL RESULT ON AS1453 = 10.08, REPEAT RESULTS ON (B)(6) = 6.13, 6.06; S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518579 ↗
• MalfunctionFeb 3, 2026False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG AND ALINITY S HBSAG AND ALINITY S HBSAG CONFIRMATORY. THE CUSTOMER REPORTED THAT THE FOLLOWING SAMPLES WERE REPEAT REACTIVE FOR ALINITY S HBSAG AND CONFIRMED WITH ALINITY S HBSAG CONFIRMATORY THE CUSTOMER REPORTED THAT FURTHER SUPPLEMENTAL TESTING WAS PERFORMED. NAT TESTING GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT TESTING OCCURRED BETWEEN 21 AND 22 DEC 2025 AND PROVIDED THE FOLLOWING DATA: REFERENCE RANGE: = 1.0 S/CO IS REACTIVE SAMPLE ID (B)(6) HBSAG RESULTS WERE 3.88, 2.95 & 2.45. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULTS WERE 152.90, 148.10, & 147.71. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULT WAS 17.37. SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULT WAS 10.08, 6.13 & 6.06. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246861 ↗
• MalfunctionJul 28, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG AND ALINITY S HBSAG CONFIRMATORY RESULTS GENERATED FOR A DONOR SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT = 1.80 S/CO, REPEATED TWICE AND RESULTS = 1.69 S/CO AND 1.68 S/CO, REPEATED WITH AN ALTERNATE METHOD AND RESULT = NON-REACTIVE. (B)(6) 2023 ALINITY S HBSAG CONFIRMATORY TEST WAS PERFORMED ON ANALYZER WITH SERIAL NUMBER AS1225, AND GENERATED POSITIVE RESULT: %N = 87.64% NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413970 ↗
• MalfunctionOct 13, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG RESULTS FOR A PATIENT DONOR. THE DONOR¿S PHYSICIAN SENT THE DONOR TO A SEPARATE LAB FOR TESTING AND THE HBSAG RESULTS WERE NEGATIVE. THE FOLLOWING DATA WAS PROVIDED (ALL THE SAME PATIENT / DIFFERENT SAMPLES): SAMPLE ID: (B)(6): ON (B)(6) 2022: INITIAL RESULT: 31.95 S/CO, REPEAT RESULT: 29.83 S/CO (HBSAG REFERENCE RANGE: < 1.00 S/CO IS NONREACTIVE, >/= 1.00 S/CO IS REACTIVE); ON (B)(6) 2022, HBSAGCF C1: 38.97 S/CO, HBSAGCF2: 15.55 S/CO, HBSAG_CONF: 60.51% NEUT (CONFIRMED POSITIVE). SAMPLE ID: (B)(6): ON (B)(6) 2022: HBSAGCF C1: 40.08 S/CO, HBSAGCF C2: 39.37 S/CO, HBSAG CONFIRMATORY RESULTS: 1.79% NEUT (INCONCLUSIVE); HBSAGCF C1: 0.33 S/CO, HBSCF C2: 0.48 S/CO, HBSAG_CONF: -230.77 % (NOT CONFIRMED); HBSAGCF C1: 40.04 S/CO, HBSAGCF C2: 16.60 S/CO, HBSAG_CONF: 58.93 % (CONFIRMED POSITIVE). SAMPLE ID: (B)(6): ON (B)(6) 2022: HBSAG INITIAL RESULT: 28.53 S/CO, REPEAT RESULT: 28.33 S/CO; ON (B)(6) 2022, HBSAGCF C1: 16.43 S/CO, HBSAGCF C2: 33.97 S/CO, HBSAG_CONF: -108.56% NEUT (INVALID); HBSAGCF C1: 10.52 S/CO, HBSAGCF C2: 11.63 S/CO, HBSAG_CONF: -10.88 % NEUT (INCONCLUSIVE); ON (B)(6) 2022: HBSAGCF C1: 29.38 S/CO, HBSAGCF C2: 24.54 S/CO,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597150 ↗
• MalfunctionOct 6, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG RESULTS FOR A PATIENT DONOR. THE DONOR¿S PHYSICIAN SENT THE DONOR TO A SEPARATE LAB FOR TESTING AND THE HBSAG RESULTS WERE NEGATIVE. THE FOLLOWING DATA WAS PROVIDED (ALL THE SAME PATIENT / DIFFERENT SAMPLES): (B)(6).: ON (B)(6) 2022: INITIAL RESULT: 31.95 S/CO, REPEAT RESULT: 29.83 S/CO (HBSAG REFERENCE RANGE: < 1.00 S/CO IS NONREACTIVE, >/= 1.00 S/CO IS REACTIVE); ON (B)(6) 2022, HBSAGCF C1: 38.97 S/CO, HBSAGCF2: 15.55 S/CO, HBSAG_CONF: 60.51% NEUT (CONFIRMED POSITIVE) (B)(6).: ON (B)(6) 2022: HBSAGCF C1: 40.08 S/CO, HBSAGCF C2: 39.37 S/CO, HBSAG CONFIRMATORY RESULTS: 1.79% NEUT (INCONCLUSIVE); HBSAGCF C1: 0.33 S/CO, HBSCF C2: 0.48 S/CO, HBSAG_CONF: -230.77 % (NOT CONFIRMED); HBSAGCF C1: 40.04 S/CO, HBSAGCF C2: 16.60 S/CO, HBSAG_CONF: 58.93 % (CONFIRMED POSITIVE) (B)(6).: ON (B)(6) 2022: HBSAG INITIAL RESULT: 28.53 S/CO, REPEAT RESULT: 28.33 S/CO; ON (B)(6) 2022, HBSAGCF C1: 16.43 S/CO, HBSAGCF C2: 33.97 S/CO, HBSAG_CONF: -108.56% NEUT (INVALID); HBSAGCF C1: 10.52 S/CO, HBSAGCF C2: 11.63 S/CO, HBSAG_CONF: -10.88 % NEUT (INCONCLUSIVE); ON (B)(6) 2022: HBSAGCF C1: 29.38 S/CO, HBSAGCF C2: 24.54 S/CO, HBSAG_CONF: 16.59% NEUT (INCONC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15553330 ↗