Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Cypress Medical Products LLC: Respiratory Strep A Test Kits Recalled for Unauthorized Distribution

Agency Publication Date: September 19, 2024
Share:
Sign in to monitor this recall

Summary

Cypress Medical Products LLC is recalling 20 kits of BinaxNOW and Acceava Respiratory Strep A medical tests because they were shipped to customers who did not have the required licenses to purchase or use them. This inventory management error affected 15 BinaxNOW kits (Catalog Number 730025) and 5 Acceava kits (Catalog Number 4580295008) distributed nationwide. Consumers who received these products without proper authorization may not have the training to interpret results correctly.

Risk

The use of these diagnostic medical devices by unlicensed or untrained individuals can lead to incorrect test results or improper clinical decisions. No injuries or specific incidents have been reported, but the lack of requisite licensing poses a risk to patient safety and diagnostic accuracy.

What You Should Do

  1. Identify if you have the affected BinaxNOW Respiratory Strep A Test Kit (Catalog Number 730025) by checking for GTIN 10811877010453 on the packaging; all lots are included.
  2. Identify if you have the affected Acceava Respiratory Strep A kit (Catalog Number 4580295008) by checking for GTIN 10815845020031 on the packaging; all lots are included.
  3. Immediately stop using the test kits if you are not a licensed medical provider authorized to possess such diagnostic equipment.
  4. Contact your healthcare provider or Cypress Medical Products LLC directly at their Richmond, Virginia office to discuss the return or proper disposal of these unauthorized kits.
  5. For further information or to report concerns, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Inventory correction and customer notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BinaxNOW Respiratory Strep A Test Kit, CLIA Waived (15 kits)
Model / REF:
730025
Z-3184-2024
UPC Codes:
10811877010453
Lot Numbers:
All Lots
Product: Acceava Respiratory Strep A, CLIA Waived (5 kits)
Model / REF:
4580295008
Z-3185-2024
UPC Codes:
10815845020031
Lot Numbers:
All Lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95235
Status: Active
Manufacturer: Cypress Medical Products LLC
Sold By: Cypress Medical Products LLC
Manufactured In: United States
Units Affected: 2 products (15 kits; 5 kits)
Distributed To: Nationwide

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.