FDA-Device2021-06-16Class II
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Hardy Diagnostics
Hazard
Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
Sold states
US Nationwide distribution in the states of AK, AR, AZ, CA, GA, KS, MA, MI, MN, MS, NY, OH, PA, RI, SC, TN, TX, WI, WV.
Affected count
69 units
Manufactured in
1430 W McCoy Ln, N/A, Santa Maria, CA, United States
Products
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1835-2021Don't want to check this manually?
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