Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2436-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 21, 2018

Date Posted: July 25, 2018

Recall Number: Z-2436-2018

Event ID: 79784

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.

Status: Terminated

Product Quantity: 1446

Code Information:

lot # 17171BD, UDI # (UDI) 008427680158927BDA3418060110445205

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated