Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205

Where it was distributed

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.

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