FDA recall Z-3184-2024

Product

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-08-20

Report date

2024-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3184-2024