Dimension Vista 1500

(1) - (2) Discrete method Clinical chemistry automatic analyzer

Model: SMN: 10488224 & 10444802, Affected: , Software version: 3.6.1, 3.6.1_MU3p, and 3.6.1SP1

All serial numbers are affected.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.

Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. || The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use

In-vitro diagnostics - equipment / products for clinical chemistry

10444802 | 3.4 and 3.5.1

IVD: Clinical chemistry analyser, centrifugal