Recall Z-1571-2025— Abbott Diagnostics Scarborough, Inc.

Name: FDA recall Z-1571-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-04

Class II · Ongoing

Class II FDA medical device recall by Abbott Diagnostics Scarborough, Inc., initiated 2025-03-04. It names one FDA 510(k) clearance: K221925. 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. Reason: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use..

Recalling firm: Abbott Diagnostics Scarborough, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-03-04
Firm location: Scarborough, ME, United States

510(k) clearances named in this recall

1 on FDA's record

K221925 — ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.·cleared 2023-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.