BenchMark ULTRA and DISCOVERY ULTRA Instruments recalled over fire hazard

Recall date

January 20, 2022

Source

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

Official notice title

Ventana Medical Systems Inc recalls BenchMark ULTRA and DISCOVERY ULTRA Instruments

Recall number

Z-0894-2022

FDA classification

Class II

Brand / firm

Ventana Medical Systems Inc

Sold / distributed

US: CA, IL, PA, FL, AZ, NY, OH, CO, AR, NC, MD, AL, AK, LA, IA, MN, MA, ND, IN, TX, TN, CT, SC, GA, UT, WI, VA, SD, KY, MS, MO, DE, MI, MT, NJ, WV, OK, WA, OR, PR, DC, NM, ID, NH, NE, ME, KS, HI, NV, RI, WY, VT OUS: Australia, Austria, Belgium, Canada, China, Croatia, Denmark, Finland, France, Germ…

Why it was recalled

Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.

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

What was recalled

BenchMark ULTRA and DISCOVERY ULTRA Instruments