Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-3184-2024

August 20, 2024

Class II

Product summary

Firm
Cypress Medical Products LLC
Event
Event 95235
Status
Ongoing
Classification
Class II
Quantity
15 kits
Official record key
device-enforcement:Z-3184-2024

Official wording

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.

Code information: GTIN: 10811877010453; All Lots

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.