Z-1573-2025 Class II Ongoing
FDA device recall Z-1573-2025 was initiated by Abbott Diagnostics Scarborough, Inc. on March 4, 2025 and is designated Class II. Reason for recall: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. The recall status is ongoing. Affected quantity: 178056 eaches (147472 US, 31584 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 178056 eaches (147472 US, 31584 OUS)
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
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.
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