Reported Jul 20, 2016 · Terminated

QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and…

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?

  • QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Lot codes and dates
  • All units manufactured between October 2014 and May 2016.
Amount recalled
25

Where it was sold

Why it was recalled

Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.

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 Mar 3, 2017 · Data as of Sep 19, 5:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.