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Hardy Diagnostics recalls QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and cou

Recalled July 20, 2016 · FDA recall Z-2146-2016 · Hardy Diagnostics

Hazard
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient. · FDA Class II
Units
25
Sold at
U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.

Description

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

Product
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Manufacturer(s)
Hardy Diagnostics

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov