Skip to content
Recall Observatory FDA recall evidence

Device product

Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System.

Z-0017-2014

December 19, 2012

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 64808
Status
Terminated
Classification
Class II
Quantity
3395
Official record key
device-enforcement:Z-0017-2014

Official wording

Reason: Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.

Code information: Lot No. 11349BB

Distribution pattern: Worldwide distribution: US (nationwide) including sates of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, ID, KY, KS, LA, MA, MD, MI, MN, MO, MS, MT, PA, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and PR; and country of: UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.