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ID NOW RSV 435-000Recalls & reported problems

Alere Scarborough, Inc. · A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens. · Class 2

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Mar 4, 2025Open, Classified

    the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

    Z-1576-2025 · Root cause: Process change control · FDA record ↗

  2. Mar 4, 2025Open, Classified

    The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

    Z-1573-2025 · Root cause: Process change control · FDA record ↗

Other Respiratory Virus Panel Nucleic Acid Assay System devices

All Respiratory Virus Panel Nucleic Acid Assay System devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.