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

Hazard

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

Details from the source

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. Quantity: 4300 ea Lot/code info: UDI-DI 008165760257704 G323 lot 653594P: Manufactured on March 6, 2025; Expires on May 15, 2025 G323 lot 655101P: Manufactured on April 4, 2025; Expires on June 13, 2025 G323 lot 656816P: Manufactured on April 16, 2025; Expires on June 25, 2025

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.