Recall Z-3184-2024— Cypress Medical Products LLC

Name: FDA recall Z-3184-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-20

Class II · Ongoing

Class II FDA medical device recall by Cypress Medical Products LLC, initiated 2024-08-20. It names one FDA 510(k) clearance: K012521. Product: BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025. Reason: 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..

Recalling firm: Cypress Medical Products LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-08-20
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K012521 — BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.·cleared 2001-11-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.