Recall Z-0017-2014— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2012-12-19, terminated 2014-08-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-19
- Terminated
- 2014-08-27
- Firm location
- Newark, DE, United States
Product description
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.
Reason for recall
Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.
Data sourced from openFDA. This site is unofficial and independent of the FDA.