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

Recall date

May 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2146-2016

FDA classification

Class II

Brand / firm

Hardy Diagnostics

Sold / distributed

U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.