Home / Recalls / Hardy Diagnostics / Z-2041-2025

Z-2041-2025 Class II Ongoing

Recalled by Hardy Diagnostics — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
July 9, 2025
Initiation Date
May 6, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4300 ea

Product Description

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 Pattern

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.

Code Information

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

Other recalls by Hardy Diagnostics

  • Z-1835-2021 Class II — Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. (April 16, 2021)
  • Z-0919-2021 Class II — Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Man (December 21, 2020)
  • Z-0655-2021 Class II — Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/ (October 23, 2020)
  • Z-0441-2021 Class III — Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 (October 6, 2020)
  • Z-2298-2020 Class II — HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic (November 14, 2019)
  • Z-2146-2016 Class II — QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematica (May 24, 2016)
  • Z-1571-2016 Class II — Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detect (March 21, 2016)
  • Z-0470-2016 Class II — FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fast (November 18, 2015)
  • Z-2463-2015 Class II — HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Ty (July 9, 2015)
  • Z-2278-2015 Class II — Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube p (June 26, 2015)