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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Abbott ID NOW COVID-19, Flu, and RSV Test Kits Recalled for Invalid Results

Agency Publication Date: April 15, 2025
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Summary

Abbott Diagnostics Scarborough, Inc. is recalling approximately 1,109,832 ID NOW COVID-19 2.0, Influenza A/B 2, and RSV test kits. These kits are being recalled because they have a higher rate of invalid test results than what is specified in the product's instructions. While no injuries have been reported, an invalid result prevents the detection of respiratory viruses and requires patients to undergo repeat testing.

Risk

The affected test kits may fail to provide a result, leading to delays in diagnosing and treating COVID-19, influenza, or RSV. This defect forces healthcare providers to re-swab patients and run additional tests, which can delay clinical decision-making.

What You Should Do

  1. This recall affects ID NOW COVID-19 2.0 24T (Model 192-000), ID NOW Influenza A/B 2 24T (Model 427-000), and ID NOW RSV 24T (Model 435-000) diagnostic test kits.
  2. Check the model number and lot number printed on the test kit packaging to determine if your product is included. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled test kits immediately and quarantine any remaining inventory.
  4. Contact Abbott Diagnostics Scarborough, Inc. or your authorized distributor to arrange for a return, replacement, or correction of the affected product.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ID NOW COVID-19 2.0 24T
Model / REF:
192-000
Lot Numbers:
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
000M926188
GTIN:
10811877011351
Date Ranges: Distributed worldwide between March 2024 and April 2025

Simple point-of-care device to detect SARS-CoV-2 nucleic acid targets.

Product: ID NOW Influenza A/B 2 24T
Model / REF:
427-000
Lot Numbers:
000M889669
000M890889
000M916327
000M916649
000M916672
000M916724
000M917131
000M917164
000M917180
000M917508
000M917581
000M919907
000M921626
000M921636
000M921728
000M923485
000M926234
000M926370
000M927991
000M928421
000M929248
000M931072
000M934181
000M939117
000M939160
000M939186
000M939468
000M939480
000M952883
GTIN:
10811877010422
Date Ranges: Distributed worldwide between March 2024 and April 2025

Multiplex nucleic acid assay for Influenza A and Influenza B.

Product: ID NOW RSV 24T
Model / REF:
435-000
Lot Numbers:
000M906790
000M907271
000M923531
000M923879
000M924414
000M924430
000M926642
000M926679
000M927161
GTIN:
10811877010521
Date Ranges: Distributed worldwide between March 2024 and April 2025

Respiratory virus panel nucleic acid assay system for RSV detection.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96519
Status: Active
Manufacturer: Abbott Diagnostics Scarborough, Inc.
Sold By: Point-Of-Care Facilities; Healthcare Providers
Manufactured In: United States
Units Affected: 3 products (339456 eaches (337560 US, 1896 OUS); 592320 eaches (535416 US, 56904 OUS); 178056 eaches (147472 US, 31584 OUS))
Distributed To: Nationwide
Agency Last Updated: May 8, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.