FDA-Device2018-07-25Class II
Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
Siemens Healthcare Diagnostics, Inc.
Hazard
The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.
Sold states
The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to Guam, Saipan, and Virgin Islands. The products were distributed to the following countries: Australia, Austria, Bahamas, Belgium, Brazil, Canada, Canary Islands, Croatia, Czech Republic, Denmark, France, Germany, Italy, Japan, Lebanon, Netherlands, Poland, Portugal, Qatar, Russian Federation, Slovakia, Slovenia, Saudi Arabia, South Korea, Spain, Switzerland, and United Arab Emirates.
Affected count
1195
Manufactured in
500 Gbc Dr Ms 514, Po Box 6101, Newark, DE, United States
Products
Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2438-2018Don't want to check this manually?
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