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-1571-2025

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 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.

Quantity

339456 eaches (337560 US, 1896 OUS)

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.

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 ****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

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

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

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