FDA Device recall Z-2436-2018
Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
- FDA Device
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205 by Siemens Healthcare Diagnostics, citing 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 sa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2436-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-21 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | 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 |
Product
Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
Reason
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.
Identifiers
| code_info | lot # 17171BD, UDI # (UDI) 008427680158927BDA3418060110445205 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2436-2018%22
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