Brand Name: ID NOW COVID-19 2.0 24T recallZ-1571-2025 · 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 FIELD CORRECTION NOTICE letters were sent to end user customers. Please complete the following actions, as applicable. 1. If you have impacted inventory in stock, then: " Discontinue use of and destroy any remaining inventory of the impacted lots according to your procedures. " Complete and return the Customer Reply Form (Form must be completed, signed and returned to receive a replacement lot). " Please retain this letter for your records. 2. If you have forwarded the product listed above to others in your network, then: - Inform them of this Field Correction Notice, provide to them a copy of this notice and request they take the necessary action. 3. If you do not have impacted inventory in stock, then: - All product lots not identified in Appendix I can continue to be used. If you have questions regarding this information, please contact Sedgwick by phone at 888 671 8858 (available 8am 5pm 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 Field Correction Notice, please immediately report the event to your local area Customer Service. ****Update added 5/8/2025**** On April 29, 2025 FIELD CORRECTION NOTICE letters were sent to customers informing them of additional lots included in this recall.

Recall details

Recall number

Z-1571-2025

Status

Open, Classified

Initiated by the company

Mar 4, 2025

Posted by the FDA

Apr 15, 2025

Recalling firm

Abbott Diagnostics Scarborough, Inc.

Quantity

339456 eaches (337560 US, 1896 OUS)

Product code

QWR

FDA submissions

K221925

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.

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 96519).

• Z-1572-2025 · 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-1573-2025 · 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…