FDA recall Z-2041-2025

Hardy Diagnostics · Class II · device

Product

HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323

Reason for recall

Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

Distribution

US domestic distribution to the following states: AZ, CA, CO, FL, GA, IL, MD, ME, MI, MN, MO, NC, NE, NV, NY, PA, PR, TX, UT, VA, WI and WV.

Key facts

Status
Ongoing
Initiation date
2025-05-06
Report date
2025-07-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2041-2025