Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of 510(k) Clearance
Hardy Diagnostics is recalling several microbiology media products, including BEA Agar with VGA, 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 classified as FDA Class II, but the source text explicitly states the reason is a lack of 510(k) clearance (a regulatory/documentation issue) and does not report any illnesses or injuries. Per the rubric, this aligns with a Moderate severity (Score 2) as a voluntary precautionary or documentation-related recall without reported harm.
Plain-English summary
Hardy Diagnostics is recalling multiple microbiology media products, including MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth. The specific product identified in the structured data is BEA Agar with VGA (Cat no. G107, Lot 15105), packaged as 15x100mm monoplates.
The recall was initiated due to the lack of FDA 510(k) clearance for these devices. The products are intended for the selective isolation of vancomycin-resistant enterococci (VRE) and other specific bacterial isolations in clinical or laboratory settings.
The affected products were distributed nationwide in the United States and in Canada. No specific illnesses or injuries have been reported in the source text. Users of these products should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
- 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: 15105 Cat no. G107
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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