medical Class II Updated 2018-07-25

Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971

Recalled Product

Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971

Hazard / Issue

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.

Issued by

FDA

Affected 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, WY

Lot/Code Info: lot # 7BDA81, UDI # (UDI) 008427680303147BDA8118030110469971

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