FDAFDA · Food and drugs·Recall number Z-0017-2014
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.
Published October 23, 2013 · Recall initiated: December 19, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- 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.
- Lot
- Lot No. 11349BB
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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