Reported Aug 5, 2015 · Terminated

Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage:…

Hardy Diagnostics

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hardy Diagnostics · 1430 W Mccoy Ln · Santa Maria, CA · 93455-1005

Is this the product you have?

  • Hardy Diagnostics
  • BEA Agar with Vancomycin container type15x100mm
  • monoplate packaged10
  • plates/sleeve Product UsageBEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures
Lot codes and dates
  • Lot number
    • 15075. 15096
    • 15107
    • 15121
    • 15134
    • and 15154 Cat no. G103
Amount recalled
5,940 (5940 pk/10)

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 11, 2015 · Data as of Sep 19, 6:03 PM UTC

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