Hardy Diagnostics Recalls Multiple Clinical Culture Media Due to Lack of Clearance
Hardy Diagnostics is recalling several clinical culture media products, including BHI with Ciprofloxacin, 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 driven by a regulatory compliance issue (lack of 510(k) clearance) rather than a reported safety hazard or injury, fitting the criteria for a moderate severity voluntary or administrative recall.
Plain-English summary
Hardy Diagnostics is recalling multiple clinical culture 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 specific product identified in the structured data is Brain Heart Infusion Broth with Ciprofloxacin, 1ug/ml, packaged in 16x100mm tubes (20 tubes/box). The affected lot numbers are 15055, 15083, and 15091.
The recall is being conducted due to the lack of FDA 510(k) clearance for these devices. The products were distributed nationwide in the United States and in Canada. The total quantity involved is 520 units (26 packages of 20).
These products are used as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples. Consumers and healthcare facilities should stop using the recalled products and contact Hardy Diagnostics for further instructions.
The recalled product
- Product
- Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical…
- 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 (3)
- Lot number: 15055
- 15083
- and 15091
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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