Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of Clearance
Hardy Diagnostics is recalling several microbiology media products, including BEA Broth with Vancomycin, because they lack FDA 510(k) clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 physical hazard or reported illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hardy Diagnostics is recalling multiple microbiology media products, including 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 being conducted because these products lack FDA 510(k) clearance.
The affected products are distributed nationwide in the United States and in Canada. Specific lot numbers and catalog numbers for the recalled items are listed in the agency's official records. These products are used for the surveillance of vancomycin-resistant enterococci (VRE) and other microbiological testing.
Consumers and healthcare facilities should stop using the affected products and contact Hardy Diagnostics for further instructions or a refund.
The recalled product
- Product
- Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility…
- 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 (5)
- Lot number: 15070 Cat no. R98 Lot number: 14193
- 14232
- 14251
- 14272
- and 14329 Cat no.: R72
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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