Abbott Diagnostics Scarborough, Inc.: 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 a

Hazard

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

Details from the source

Reason for recall: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. 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. Quantity: 178056 eaches (147472 US, 31584 OUS) 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

UPC codes

10811877010521

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.