Alinity m 08N50-095Recalls & reported problems
Abbott Molecular Inc. · Alinity m HCV AMP Kit · Class 2
All models of Alinity m (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884999047761), received between Nov 7, 2023 and Nov 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Oct 30, 2023Open, Classified
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
Z-0407-2024 · Root cause: Other · Recall details · FDA record ↗
Most reported problems
Device problems
- False Positive Result1
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2023False Positive Result; Unable to Obtain Readings; False Positive Result; Unable to Obtain Readings
THROUGH COMPLAINT INVESTIGATION, ABBOTT HAS IDENTIFIED AN INCREASE IN POTENTIAL FOR REACTIVE NEGATIVE CONTROLS (NC) AS WELL AS SEPARATE INSTANCES OF FALSE POSITIVE RESULTS IN PATIENT SAMPLES WHEN USING SPECIFIC LOTS OF ALINITY M HCV AMP KIT. IT WAS DISCOVERED THAT THESE SPECIFIC LOTS OF ALINITY M HCV AMP KIT HAVE LOWER THAN THE EXPECTED RANGE OF HCV REFERENCE DYE FLUORESCENCE. A PRODUCT DEFICIENCY WAS IDENTIFIED FOR THESE SPECIFIC LOTS OF ALINITY M HCV ASSAY. THE POTENTIAL HAZARDS ASSOCIATED WITH THIS ISSUE ARE INCORRECT RESULTS (FALSE POSITIVE) AND DELAY OF RESULTS (REACTIVE NC REQUIRING A RE-TEST). FIELD ACTION FA-AM-OCT2023-293, WAS TAKEN TO ADDRESS THIS ISSUE. IT WAS DEEMED REPORTABLE PER 21CFR806 AND THEREFORE WILL BE REPORTED UNDER 21CFR803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18089017 ↗
Other Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus devices
- cobas 8800 System 05412722001Roche Diagnostics GmbH · ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS6 reports
- cobas 6800 System 05524245001Roche Diagnostics GmbH · ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS5 reports
- cobas® NHP Negative Control Kit 1.0Roche Diagnostics GmbH · ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS2 reports
- cobas® HCV 09040765190Roche Molecular Systems, Inc. · Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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