Brand Name: ID NOW COVID-19 2.0 24T recallZ-1574-2025 · Abbott Diagnostics Scarborough, Inc. · initiated Mar 4, 2025

Why it was recalled

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

FDA root cause category: Process change control

What the company is doing

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.

Recall details

Recall number

Z-1574-2025

Status

Open, Classified

Initiated by the company

Mar 4, 2025

Posted by the FDA

Apr 15, 2025

Recalling firm

Abbott Diagnostics Scarborough, Inc.

Quantity

2,164,872 eaches

Product code

QWR

FDA submissions

K221925

Distribution

US Nationwide distribution.

Product description

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

Other devices under the same FDA submission

1 device cleared under K221925 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• ID NOW COVID-19 2.0 192-000

  Alere Scarborough, Inc. · Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
  147 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 96500).

• Z-1575-2025 · Open, Classified
  Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B…
• Z-1576-2025 · Open, Classified
  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 C…