FDA-Device2016-07-20Class II
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Hardy Diagnostics
Hazard
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
Sold states
U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
Affected count
25
Manufactured in
1430 W McCoy Ln, Santa Maria, CA, United States
Products
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2146-2016Don't want to check this manually?
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