HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No.
Summary
The FDA issued a Class II for HardyCHROM CRE, selective and differential culture medium for antimicrobial susc by Hardy Diagnostics. Reason: Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae..
Details
Source
Device Recall
External ID
Z-2041-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
Product Description
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
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
Quantity Affected: 4300 ea
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-06
Company
Santa Maria, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hardy Diagnostics has 9 FDA actions in our database, including 1 recall and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hardy Diagnostics) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hardy Diagnostics have FDA actions?
Hardy Diagnostics has 9 FDA actions in our database, including 1 recall and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2041-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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