FDA Device recall Z-2175-2012
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086)
- FDA Device
- Class III
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class III recall of Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086) by Siemens Healthcare Diagnostics, citing siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VAN….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2175-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-07-17 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WV |
Product
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.
Reason
Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System.
Identifiers
| code_info | lot 12095AD, exp 2013-04-04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2175-2012%22
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