FDAFDA · Food and drugs·Recall number Z-2146-2016
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Published July 20, 2016 · Recall initiated: May 24, 2016
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
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Hardy Diagnostics
- Distributor
- U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
- Lot
- All units manufactured between October 2014 and May 2016.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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