Hardy Diagnostics Recalls Multiple Microbiological Media Due to Lack of 510(k) Clearance
Hardy Diagnostics is recalling several microbiological media products, including BEA Agar with Vancomycin, because they lack FDA 510(k) clearance.
What this means for you
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 documentation and regulatory compliance issue. There are no reported injuries, illnesses, or product defects, fitting the criteria for a Low severity score.
Plain-English summary
Hardy Diagnostics is voluntarily recalling multiple microbiological 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 for the BEA Agar with Vancomycin product include 15075, 15096, 15107, 15121, 15134, and 15154, with catalog number G103. The total quantity recalled for this specific product is 5,940 units.
Consumers and healthcare facilities should stop using these products and contact Hardy Diagnostics for further instructions or a refund. The recall is administrative in nature, addressing regulatory compliance rather than a reported safety hazard or product defect.
The recalled product
- Product
- Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vanco
- Manufacturer
- Hardy Diagnostics
- Hazard
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: 15075. 15096
- 15107
- 15121
- 15134
- and 15154 Cat no. G103
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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