Lower riskMedical device recall · FDA · Published August 20, 2024
Cypress Medical BinaxNOW Strep A Test Kit Recall: License Purchase Error
Cypress Medical recalls BinaxNOW Respiratory Strep A Test Kits due to shipping to customers without required licenses. No action needed as the issue is a licensing error, not a product defect.
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Take action
Contact the company
📍Recalling firmCypress Medical Products LLC9954 Mayland Dr · Richmond, VA 23233-1464
“Cypress Medical BinaxNOW Strep A Test Kit Recall: License Purchase Error.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/54196-cypress-medical-binaxnow-strep-a-test-kit-recall-license-purchase. Based on FDA recall #Z-3184-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3184-2024%22&limit=1).
The FDA announced on August 20, 2024, that Cypress Medical Products LLC is recalling the BinaxNOW Respiratory Strep A Test Kit due to a classification error. The agency stated the devices were shipped to customers lacking the requisite license to purchase them.
How to tell if you have it
Brand: Cypress Medical
Product: BinaxNOW Respiratory Strep A Test Kit, CLIA Waived
Catalog Number: 730025
UPC: 10811877010453
Distribution: US Nationwide
The hazard
The recall is due to a classification error in the company's inventory management system. This error resulted in medical devices being shipped to customers who did not have the requisite license to purchase such devices.
Context
GovInfoNow's records show Cypress Medical Products LLC has 7 other recalls on record since November 17, 2017. Other recent recalls of similar products include Medline ENT Kits Recall: 510(k) Clearances Rescinded for Medical Devices (February 25, 2026), Braun Medical Spinal Needle Kits Recall: Potential Quality Issues with Bupivacaine (May 6, 2026), and Leaky Gut Test Product Recall: Distribution Without Premarket Approval (November 3, 2025).
How to tell if you have this one
Check for the BinaxNOW Respiratory Strep A Test Kit with Catalog Number 730025. All lots are affected. The product has a GTIN of 10811877010453.
Brand
Cypress Medical
Product
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-3184-2024
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025; GTIN: 10811877010453; All Lots
15 kits
Z-3185-2024
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008; GTIN: 10815845020031; All Lots
5 kits
Based on the official FDA remedy
What to do — step by step
Check License Status
Verify if you have the required license to purchase medical devices from the manufacturer's website or your state health department.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3184-2024 (August 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3184-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.