Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Ve...

FDA Device Recall #Z-1576-2025 — Class II — March 4, 2025

Recall Summary

Recall Number Z-1576-2025
Classification Class II — Moderate risk
Date Initiated March 4, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Abbott Diagnostics Scarborough, Inc.
Location Scarborough, ME
Product Type Devices
Quantity 442,296 eaches

Product Description

Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

Model 435-000; GTIN/DI 10811877010521; Lot 000M906790 Model 435-000; GTIN/DI 10811877010521; Lot 000M907271 Model 435-000; GTIN/DI 10811877010521; Lot 000M923531 Model 435-000; GTIN/DI 10811877010521; Lot 000M923879 Model 435-000; GTIN/DI 10811877010521; Lot 000M924414 Model 435-000; GTIN/DI 10811877010521; Lot 000M924430 Model 435-000; GTIN/DI 10811877010521; Lot 000M926642 Model 435-000; GTIN/DI 10811877010521; Lot 000M926679 Model 435-000; GTIN/DI 10811877010521; Lot 000M927161

Other Recalls from Abbott Diagnostics Scarborough, Inc.

Recall # Classification Product Date
Z-1565-2026 Class II Product Name: ID NOW" Influenza A & B 2 Model/... Feb 9, 2026
Z-1575-2025 Class II Brand Name: ID NOW Influenza A/B 2 24T Product ... Mar 4, 2025
Z-1572-2025 Class II Brand Name: ID NOW Influenza A/B 2 24T Product ... Mar 4, 2025
Z-1574-2025 Class II Brand Name: ID NOW COVID-19 2.0 24T Product Nam... Mar 4, 2025
Z-1573-2025 Class II Brand Name: ID NOW RSV 24T Product Name: ID NOW... Mar 4, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.