FDA Medical Device Recalls (openFDA)
Abbott Diagnostics Scarborough, Inc.: 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
- Recall number
- Z-1574-2025
- Recalling firm
- Abbott Diagnostics Scarborough, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2025-03-04
- Posted
- 2025-04-15
- Terminated
- not on file
- Reason
- the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Root cause
- Process change control
- Action
- On March 4, 2025 PRODUCT REMOVAL NOTICE letters were sent to distributors. Necessary Actions to be Taken by Distributor: 1. If you have impacted inventory held in stock, then: "Immediately quarantine impacted product per your local procedure. "Complete and return the Distributor Acknowledgment Form (Form must be completed, signed and returned to receive replacement product). "Contact Customer Service to arrange return of your product by Abbott. 2. If you have forwarded the product listed above to others within your distribution network, then: "Inform them of this Product Removal Notice and provide to them a copy of this notice and request they take the necessary action. 3. If you have forwarded the impacted product to your customers, then: "Provide customer list to Abbott based on the product information in Appendix II as outlined in the distribution agreement within 48 hours of receipt of this Product Removal Notice. "Abbott will notify customers of this Product Removal Notice. 4. If you do not have any inventory of the impacted lot(s), then: "All product lots not identified in Appendix I can continue to be used. If you have questions regarding this information, U.S. Customers please contact Sedgwick at 1 888 671 8858 (available 8am 6pm EST, Monday - Friday). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online (http://www.fda.gov/MedWatch/report.htm), by mail (http://www.fda.gov/MedWatch/getforms.htm), by phone (1-800-332-1088), or by fax (1-800-FDA-0178). If you have experienced any patient or user injury associated with this Removal Notice, please immediately report the event to your local area Customer Service. ****Update 05/08/2025**** On April 29, 2025 Updated PRODUCT REMOVAL NOTICE letters were sent to distributors notifying of additional lots that were included in the recall.
- Quantity
- 2,164,872 eaches
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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 ****Update 4/29/2025**** 04/29/2025 (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 000M924019 Model No 192-000; GTIN/DI 10811877011351; Lot 000M924386 Model No 192-000; GTIN/DI 10811877011351; Lot 000M926188
- 510(k) numbers
- ["K221925"]
- PMA numbers
- not on file
- Product code
- QWR
- Firm FEI
- 1221359
- Firm city
- Scarborough
- Firm state
- ME
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28