Reported Jul 29, 2015 · Terminated

HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged:…

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?

  • HardyCHROM VRE Agar-RSR Cat noGA333
  • Lot noH15055
  • Expires2015-07-04
  • Container type15x100mm
  • monoplate Packaged10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening
Lot codes and dates
  • Cat No.: G333 Lot No.: H15055
Amount recalled
1,500

Where it was sold

Why it was recalled

Hardy Diagnostics is recalling HardyCHROM VRE Agar 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 Aug 28, 2015 · Data as of Sep 19, 5:19 PM UTC

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