Alinity 04W5660Recalls & reported problems
Abbott GmbH · Alinity s Anti-HCV II Reagent Kit
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740177706), received between Jun 5, 2024 and Jul 23, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2025False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HCV II RESULTS FOR NUMEROUS TISSUE AND ORGAN DONORS. THE CUSTOMER REPORTED THAT FOR TISSUE DONORS FROM (B)(6) 2025, 24 DONOR SAMPLES WERE REPEAT REACTIVE WITH THE ALINITY S ANTI-HCV ASSAY. THOSE 24 REACTIVE SAMPLES WERE TESTED WITH NAT AND 19 SAMPLES WERE NEGATIVE. THOSE 19 CONFIRMED NEGATIVE SAMPLES WERE THEN TESTED WITH AN ORTHO ANTI-HCV ASSAY AND 13 WERE NONREACTIVE AND 6 WERE REACTIVE. THE CUSTOMER WAS USING ORTHO ANTI-HCV AS THEIR PRIMARY MEANS OF TESTING TISSUE DONORS FROM (B)(6) 2024 TO (B)(6), 2025, AND THERE WERE 13 DONOR SAMPLES THAT WERE REPEAT REACTIVE. THOSE 13 SAMPLES WERE TESTED WITH NAT AND 8 WERE NEGATIVE. THE 8 CONFIRMED NEGATIVES SAMPLES WERE TESTED WITH THE ALINITY S ANTI-HCV ASSAY AND 3 WERE NONREACTIVE AND 5 WERE REPEAT REACTIVE. THE CUSTOMER REPORTED THAT FOR ORGAN DONORS FROM (B)(6) 2025, 20 DONOR SAMPLES WERE REPEAT REACTIVE WITH THE ALINITY S ANTI-HCV ASSAY. THOSE 20 REACTIVE SAMPLES WERE TESTED WITH NAT AND 8 SAMPLES WERE NEGATIVE. THOSE 8 CONFIRMED NEGATIVE SAMPLES WERE THEN TESTED WITH AN ORTHO ANTI-HCV ASSAY AND 3 WERE NONREACTIVE AND 5 WERE REACTIVE. THE CUSTOMER WAS USING ORTHO ANTI-HCV AS THEIR PRI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22582816 ↗MalfunctionJul 23, 2025False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HCV II RESULTS FOR NUMEROUS TISSUE AND ORGAN DONORS. THE CUSTOMER REPORTED THAT FOR TISSUE DONORS FROM (B)(6) 2025, 24 DONOR SAMPLES WERE REPEAT REACTIVE WITH THE ALINITY S ANTI-HCV ASSAY. THOSE 24 REACTIVE SAMPLES WERE TESTED WITH NAT AND 19 SAMPLES WERE NEGATIVE. THOSE 19 CONFIRMED NEGATIVE SAMPLES WERE THEN TESTED WITH AN ORTHO ANTI-HCV ASSAY AND 13 WERE NONREACTIVE AND 6 WERE REACTIVE. THE CUSTOMER WAS USING ORTHO ANTI-HCV AS THEIR PRIMARY MEANS OF TESTING TISSUE DONORS FROM (B)(6) 2024 TO (B)(6) 2025, AND THERE WERE 13 DONOR SAMPLES THAT WERE REPEAT REACTIVE. THOSE 13 SAMPLES WERE TESTED WITH NAT AND 8 WERE NEGATIVE. THE 8 CONFIRMED NEGATIVES SAMPLES WERE TESTED WITH THE ALINITY S ANTI-HCV ASSAY AND 3 WERE NONREACTIVE AND 5 WERE REPEAT REACTIVE. THE CUSTOMER REPORTED THAT FOR ORGAN DONORS FROM (B)(6) 2025, 20 DONOR SAMPLES WERE REPEAT REACTIVE WITH THE ALINITY S ANTI-HCV ASSAY. THOSE 20 REACTIVE SAMPLES WERE TESTED WITH NAT AND 8 SAMPLES WERE NEGATIVE. THOSE 8 CONFIRMED NEGATIVE SAMPLES WERE THEN TESTED WITH AN ORTHO ANTI-HCV ASSAY AND 3 WERE NONREACTIVE AND 5 WERE REACTIVE. THE CUSTOMER WAS USING ORTHO ANTI-HCV AS THEIR PRIM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22582724 ↗MalfunctionMar 20, 2025False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HCV II RESULTS FOR 21 SPECIMENS, WHILE THE HCV RESULTS WITH GRIFOLS NAT AND/OR ORTHO ELISA WERE NEGATIVE. THERE WAS NO SPECIFIC ACTUAL PATIENT OR DONOR RESULTS PROVIDED BY THE CUSTOMER. THERE WAS NO REPORTED IMPACT ON PATIENT OR DONOR MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21652244 ↗MalfunctionMar 20, 2025False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HCV II RESULTS FOR 21 DONORS, WHILE THE HCV RESULTS WITH GRIFOLS NAT AND/OR ORTHO ELISA WERE NEGATIVE. THERE WAS NO SPECIFIC ACTUAL PATIENT OR DONOR RESULTS PROVIDED BY THE CUSTOMER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21652059 ↗MalfunctionJun 5, 2024False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HCV II RESULTS FOR LIVING ORGAN SAMPLES THAT WERE NOT CONSISTENT WITH NAT TESTING. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SAMPLE ID (B)(6) INITIAL RESULT ON ANALYZER (B)(6) = 87.59 S/CO, REPEAT RESULT = 86.24 S/CO, 87.93 S/CO, 89.36 S/CO, 88.67 S/CO (B)(6) 2024 SAMPLE ID (B)(6) INITIAL RESULT ON ANALYZER (B)(6) = 82.81 S/CO, REPEAT RESULTS = 83.54 S/CO, 84.31 S/CO, 79.80 S/CO PATIENT MEDICAL HISTORY: BOTH ORGAN DONORS HAVE A KNOWN PAST MEDICAL HISTORY OF HCV AND/OR HBV. CUSTOMER STATED THAT DUE TO INCREASED REACTIVE RESULTS, THEY WANT ALL POSITIVES/REACTIVES INVESTIGATED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19466482 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.