Cypress Medical Products LLC recalls BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

Recall date

August 20, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3184-2024

FDA classification

Class II

Brand / firm

Cypress Medical Products LLC

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025