Reported Sep 2, 2015 · Terminated

HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10…

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 MRSA Cat noG307
  • Lot noH15155
  • Expires2015-08-13
  • Container Type15x100mm
  • monoplate Packaged10
  • plates/sleeve Storage2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
Lot codes and dates
  • Cat no. G307 Lot no. H15155
Amount recalled
2,820 (282 pk/10)

Where it was sold

Why it was recalled

Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.

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 Nov 10, 2015 · Data as of Sep 19, 4:48 PM UTC

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