Recall Z-2041-2025— Hardy Diagnostics

Name: FDA recall Z-2041-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-06

Class II · Ongoing

Class II FDA medical device recall by Hardy Diagnostics, initiated 2025-05-06. It names one FDA 510(k) clearance: K190553. Product: HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323. Reason: Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae..

Recalling firm: Hardy Diagnostics
Classification: Class II
Status: Ongoing
Initiated: 2025-05-06
Firm location: Santa Maria, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K190553 — HardyCHROM CREHardy Diagnostics·cleared 2019-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.