Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Desc
Summary
The FDA issued a Class II for Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 43 by Abbott Diagnostics Scarborough, Inc.. Reason: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use..
Details
Source
Device Recall
External ID
Z-1576-2025
Action Date
2025-04-23
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 442,296 eaches
Reason for Recall
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-04
Company
Scarborough, ME
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Diagnostics Scarborough, Inc. has 12 FDA actions in our database, including 7 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Diagnostics Scarborough, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Diagnostics Scarborough, Inc. have FDA actions?
Abbott Diagnostics Scarborough, Inc. has 12 FDA actions in our database, including 7 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1576-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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