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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

ID NOW COVID-19, Flu, and RSV Test Kits Recalled for High Invalid Result Rates

Agency Publication Date: April 15, 2025
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Summary

Abbott Diagnostics Scarborough, Inc. has recalled approximately 5,383,584 ID NOW diagnostic test kits, including ID NOW COVID-19 2.0, ID NOW Influenza A/B 2, and ID NOW RSV. These kits are being recalled because certain lots show a higher rate of "invalid" test results than expected. While no injuries have been reported, an invalid result prevents healthcare providers from accurately diagnosing a patient's condition. These test kits were distributed nationwide to hospitals, clinics, and other point-of-care facilities through authorized distributors.

Risk

An invalid test result means the device cannot provide a clear positive or negative diagnosis for COVID-19, the flu, or RSV. This failure can lead to delays in patient treatment or the need for repeated testing procedures.

What You Should Do

  1. This recall affects ID NOW COVID-19 2.0, ID NOW Influenza A/B 2, and ID NOW RSV test kits manufactured by Abbott Diagnostics Scarborough, Inc.
  2. Identify if your kits are affected by checking the model number and lot number on the product packaging. Affected models include 192-000 (COVID-19), 427-000 (Flu), and 435-000 (RSV).
  3. Check your specific lot numbers against the hundreds of affected codes, such as lot 000M884910 for COVID-19 or 000M889669 for Influenza. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  5. Call the FDA at 1-888-463-6332 for additional questions regarding this medical device 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
Variants: 24-test kit
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
000M924019
000M924386
000M926188
GTIN:
10811877011351

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets.

Product: ID NOW Influenza A/B 2 24T
Variants: 24-test kit
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

Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid.

Product: ID NOW RSV 24T
Variants: 24-test kit
Model / REF:
435-000
Lot Numbers:
000M906790
000M907271
000M923531
000M923879
000M924414
000M924430
000M926642
000M926679
000M927161
GTIN:
10811877010521

Respiratory virus panel nucleic acid assay system.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96500
Status: Active
Manufacturer: Abbott Diagnostics Scarborough, Inc.
Sold By: Authorized distributors; Point-of-care facilities
Manufactured In: United States
Units Affected: 3 products (2,164,872 eaches; 2,776,416 eaches; 442,296 eaches)
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.