Hardy Diagnostics is recalling approximately 4,300 units of HardyCHROM CRE, a laboratory culture medium used to test for antimicrobial susceptibility. The recall was initiated because several lots failed quality control testing by allowing the breakthrough growth of Klebsiella pneumoniae, a type of bacteria the medium is designed to select or differentiate. This affects Catalog No. G323 distributed across 21 states and Puerto Rico between March and June 2025.
The failure of the culture medium to correctly identify or inhibit bacteria can result in inaccurate laboratory test results. Inaccurate results may lead to an incorrect diagnosis or the administration of inappropriate medical treatments for patients with infections.
Quantity affected: 4300 ea
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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