Class II
Medical Device Recall: BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Cypress Medical Products LLC · August 20, 2024
Reason for Recall
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
15 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3184-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.