FDA recall Z-3185-2024

Cypress Medical Products LLC · Class II · device

Product

Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

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-3185-2024