The Recall Desk
ModerateFDA (Devices)·Z-1574-2025·Announced 2025-04-23

ID NOW COVID-19 2.0 24T Point-of-Care Device Recall

Abbott Diagnostics is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher-than-expected rates of invalid test results. The affected devices were distributed nationwide.

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. The hazard is invalid test results (a performance/accuracy defect) with no reported illnesses or injuries. The source text explicitly states only that invalid rates are higher than expected, which constitutes a functional defect without known adverse health consequences.

Plain-English summary

Abbott Diagnostics Scarborough, Inc. is recalling multiple lots of the ID NOW COVID-19 2.0 24T, a point-of-care device designed to detect SARS-CoV-2 nucleic acid targets. The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Approximately 2,164,872 devices in these lots were distributed nationwide. The affected lot numbers include 000M884910, 000M885121, 000M911157, 000M913227, 000M913286, 000M913303, 000M913641, 000M914188, 000M914221, 000M914852, 000M915373, 000M916267, 000M921404, 000M922204, 000M922578, 000M922601, 000M922634, 000M924048, 000M925615, 000M938692, 00M922634A, 00M924048A, 000M913147, 000M913159, 000M922950, 000M922988, 000M924019, 000M924386, and 000M926188 (Model No 192-000; GTIN/DI 10811877011351).

Healthcare facilities and laboratories using affected devices should contact Abbott Diagnostics Scarborough, Inc. for guidance on device replacement or return. Users should verify their device lot number against the recall list before continued use.

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 Device
Hazard
  • test-accuracy
  • invalid-results

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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