Dimension Vista¿ CTNI Sample Diluent — Class II medical device recall Z-2436-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-07-25, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective s
| Recall number | Z-2436-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2018-03-21 |
| Classified | 2018-07-13 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2020-06-12 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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 |
| Countries outside the US | AE, AT, AU, BE, BR, BS, CA, CH, CZ, DE, DK, ES, FR, HR, IT, JP, KR, LB, NL, PL, PT, QA, SA, SI, SK |
| Quantity | 1,446 |
| Lot numbers | 17171BD |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2436-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.