ID NOW Influenza A & B 2 427-000Recalls & reported problems
Alere Scarborough, Inc. · A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10811877010422), received between Mar 1, 2024 and Mar 10, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (1 report).
3 FDA recall records name this device's identifier, 3 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 18, 2026.
Reports received per month
Recalls naming this device
- Feb 9, 2026Class IIOpen, Classified
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Z-1565-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 4, 2025Class IIOpen, Classified
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Z-1572-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Mar 4, 2025Class IIOpen, Classified
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Z-1575-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- False Negative Result1
- False Positive Result1
Patient problems
- Cardiac Arrest1
- Hypoxia1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW INFLUENZA A/B 2.0 ASSAY PERFORMED ON (B)(6) 2025 ON A NASAL SAMPLE. THE PATIENT WAS SENT HOME WITHOUT TREATMENT. THE PATIENT WAS REPORTED TO HAVE STARTED EXPERIENCING SYMPTOMS THAT DAY, AND THEY WORSENED FOLLOWING THE OFFICE VISIT. FOUR HOURS LATER, THE PATIENT WENT TO THE EMERGENCY ROOM, WHERE CONFIRMATION PCR (UNKNOWN PLATFORM) TESTING WAS PERFORMED GENERATING A POSITIVE RESULT. THE PATIENT WAS REPORTED TO BE EXPERIENCING THE FOLLOWING SYMPTOMS AT HOME, PRIOR TO THE EMERGENCY ROOM VISIT: HYPOXIA, RESPIRATORY DISTRESS, DIFFICULTY BREATHING, AND SHORTNESS OF BREATH. THE PATIENT WAS HOSPITALIZED AND RECEIVED TREATMENT (UNKNOWN TYPE). ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT OUTCOME WAS PROVIDED.
Patient problems: Hypoxia
MAUDE report 21567762 ↗MalfunctionMar 1, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW INFLUENZA A/B ASSAY PERFORMED ON AN UNKNOWN DATE. THE CUSTOMER REPORTED THAT THE PATIENT WAS SENT HOME AND AFTER FEW DAYS HAD A CARDIAC ARREST AT HOME AND DIED. THE POSTMORTEM REPORT CONFIRMED THAT THE PATIENT WAS NOT FLU B POSITIVE. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: Cardiac Arrest; Insufficient Information
MAUDE report 18817858 ↗
Other Devices Detecting Influenza A, B, And C Virus Antigens devices
- BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit 256045Becton, Dickinson And Company · Devices detecting influenza A, B, and C virus antigens251 reports
- BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit 256041Becton, Dickinson And Company · Devices detecting influenza A, B, and C virus antigens82 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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