The Recall Desk
ModerateFDA (Devices)·Z-1571-2025·Announced 2025-04-23

ID NOW COVID-19 2.0 Point-of-Care Test Device Recall

Abbott is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher invalid result rates than stated in product instructions. The affected lots were distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is elevated invalid test rates, which represents a performance/reliability issue rather than direct physical harm. Class II recalls without reported adverse health outcomes typically score 2 per the rubric.

Plain-English summary

Abbott Diagnostics Scarborough, Inc. is recalling specific lots of the ID NOW COVID-19 2.0 24T point-of-care test device. The device is used to detect SARS-CoV-2 nucleic acid targets.

The affected lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. This means the device may produce invalid test results at a higher frequency than expected.

The recall affects 339,456 units (337,560 in the US and 1,896 outside the US) distributed to 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, and Uruguay.

If you have one of the affected lots, contact Abbott or your local health authority for instructions on replacement or proper device disposal.

The recalled product

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
Manufacturer
Abbott Diagnostics Scarborough, Inc.
Category
Medical Device — Diagnostic Test / Point-of-Care
Hazard
  • invalid-results
  • performance-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No 192-000
  • GTIN/DI 10811877011351
  • Lot 000M884910 Model No 192-000
  • Lot 000M885121 Model No 192-000
  • Lot 000M911157 Model No 192-000
  • Lot 000M913227 Model No 192-000
  • Lot 000M913286 Model No 192-000
  • Lot 000M913303 Model No 192-000
  • Lot 000M913641 Model No 192-000
  • Lot 000M914188 Model No 192-000
  • Lot 000M914221 Model No 192-000
  • Lot 000M914852 Model No 192-000
  • Lot 000M915373 Model No 192-000
  • Lot 000M916267 Model No 192-000
  • Lot 000M921404 Model No 192-000
  • Lot 000M922204 Model No 192-000
  • Lot 000M922578 Model No 192-000
  • Lot 000M922601 Model No 192-000
  • Lot 000M922634 Model No 192-000
  • Lot 000M924048 Model No 192-000

Distribution

Distributed nationwide across the United States.

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