Hardy Diagnostics Recalls VRE Broth and Other Media for Lack of Clearance
Hardy Diagnostics is recalling VRE Broth and other diagnostic media because they lack FDA 510(k) clearance. The products were distributed in the U.S. and Canada.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a lack of 510(k) clearance, which is a regulatory and documentation issue rather than a direct safety hazard or defect causing injury.
Plain-English summary
Hardy Diagnostics is recalling several diagnostic media products, including VRE Broth, 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, and BEA Broth with Vancomycin. The recall is being conducted because the products lack FDA 510(k) clearance.
The affected products were distributed nationwide in the United States and in Canada. Specific lot numbers for the VRE Broth include 15021, 15043, 15072, 15126, and 15152, with catalog number K103. The quantity involved is 900 units.
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 VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
- 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: 15021
- 15043
- 15072
- 15126
- 15152 Cat no. K103
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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