FDAFDA · Food and drugs·Recall number Z-2277-2015
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).
Published August 5, 2015 · Recall initiated: June 26, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Hardy Diagnostics is recalling 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 due to lack of 510(k) clearance.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Hardy Diagnostics
- Distributor
- U.S. Nationwide Distribution and the country of: Canada
- Lot
- Lot number: 15105 Cat no. G107
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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