# FDA recall Z-2436-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-03-21.

## Product

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

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-2436-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-21
- **Report date:** 2018-07-25
- **Termination date:** 2020-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2436-2018

## Citation

> AI Analytics. FDA recall Z-2436-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2436-2018. Source: US FDA. Licensed CC0.

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