FDA Medical devices recall ·
ID NOW RSV 24T Product Name: ID NOW RSV 24T Model recall
- Recall number
- Z-1573-2025
- Date
- (initiated March 4, 2025)
- Company / brand
- Abbott Diagnostics Scarborough, Inc.
10 Southgate Rd, Scarborough, ME, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 178056 eaches (147472 US, 31584 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide distribution - US Nationwide and the countries of Australia; Austria; Belgium; Bulgaria; Canada; Costa Rica; France; French Polynesia; Germany; Italy; Luxembourg; Malaysia; Netherlands; Paraguay; Poland; Qatar; Saudi Arabia; Slovenia; South Korea; Spain; Switzerland; Taiwan; United Kingdom; Uruguay.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1573-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.