Device product
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
Z-1571-2025
Product summary
- Event
- Event 96519
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 339456 eaches (337560 US, 1896 OUS)
- Official record key
device-enforcement:Z-1571-2025
Official wording
Reason: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Code information: Model No 192-000; GTIN/DI 10811877011351; Lot 000M884910 Model No 192-000; GTIN/DI 10811877011351; Lot 000M885121 Model No 192-000; GTIN/DI 10811877011351; Lot 000M911157 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913227 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913286 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913303 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913641 Model No 192-000; GTIN/DI 10811877011351; Lot 000M914188 Model No 192-000; GTIN/DI 10811877011351; Lot 000M914221 Model No 192-000; GTIN/DI 10811877011351; Lot 000M914852 Model No 192-000; GTIN/DI 10811877011351; Lot 000M915373 Model No 192-000; GTIN/DI 10811877011351; Lot 000M916267 Model No 192-000; GTIN/DI 10811877011351; Lot 000M921404 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922204 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922578 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922601 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922634 Model No 192-000; GTIN/DI 10811877011351; Lot 000M924048 Model No 192-000; GTIN/DI 10811877011351; Lot 000M925615 Model No 192-000; GTIN/DI 10811877011351; Lot 000M938692 Model No 192-000; GTIN/DI 10811877011351; Lot 00M922634A Model No 192-000; GTIN/DI 10811877011351; Lot 00M924048A ****Updated 5/8/2025**** 04/29/2025 (Adding Additional Lots): Model No 192-000; GTIN/DI 10811877011351; Lot 000M913147 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913159 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922950 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922988 Model No 192-000; GTIN/DI 10811877011351; Lot 000M926188
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.
Derived failure modes
-
Unknown
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.