Hardy Diagnostics Recalls MacConkey Agar and Other Media for Lack of Clearance
Hardy Diagnostics is recalling specific lots of MacConkey Agar and other diagnostic media because they lack FDA 510(k) clearance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is due to a regulatory documentation issue (lack of 510(k) clearance) rather than a direct safety hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth. The recall is due to the lack of FDA 510(k) clearance for these products.
The affected products include MacConkey Agar with Ciprofloxacin, which is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples. The specific lot numbers involved in the recall are 15096 and 15107. The products were distributed nationwide in the United States and in Canada.
Consumers and healthcare facilities should stop using these products and contact Hardy Diagnostics for further instructions or a refund.
The recalled product
- Product
- Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical s
- Manufacturer
- Hardy Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 15096 and 15107
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Hardy Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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