Z-2041-2025Class II

HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product...

Name: Z-2041-2025 HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product...
Creator: Hardy Diagnostics
Published: 2025-05-06
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2025-05-06 / Open, Classified / root cause: manufacturing process

FDA source

Hardy Diagnostics began a recall of HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323 on 2025-05-06. FDA classified it as Class II and gives the reason as "Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2041-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-06
Posted: 2025-06-27
Recalling firm: Hardy Diagnostics
Product: HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On May 6, 2025, the firm began notifying customers via "URGENT Medical Device Recall Notification" letters. Customers were instructed to discard any remaining stock and to destroy it according to local regulations. If product was further distributed, notify the consignees who received the product. Please retain this letter or post the letter where the product is stored to ensure the users are aware of this defect. For replacements or credit, please contact the firm's Technical Services Department at (800) 266-2222, option 2 or via email at [email protected]. Replacements will be sent out at no-charge to your laboratory or a credit will be applied to your invoice upon request. If you have any questions, call 805-346-2766 or email: [email protected].
Quantity in commerce: 4300 ea
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2041-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2041-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-06-27

Product code JSO

K190553Class IIHardyCHROM CREHardy Diagnostics / cleared 2019-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)