Recall Z-0017-2014
Siemens Healthcare Diagnostics, Inc. · initiated December 19, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot No. 11349BB
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.
FDA-determined cause: Process control
Action taken
The firn, Siemens, sent an "Urgent Medical Device Correction" letter (dated December 2012) was provided to all Dimension Vista (R) UCFP customers who have received UCFP lot 11349BB. The letter described the product, problem and actions to be taken. The customers are instructed to discontinue use and discard any remaining inventory of Dimension Vista UCFP lot 11349BB; provide instructions for product replacement; and complete and return the attacted REQUEST FOR REPLACEMENT FORM via fax to (302) 631-8467. Siemens will replace any un-used inventory of this lot, at no charge. If you have any questions, please contact your Siemens Technical Solutions Center. your local Siemens Technical Support Representative or 800-441-9250.
Details
- Recall number
- Z-0017-2014
- Initiated
- December 19, 2012
- Posted by FDA
- October 17, 2013
- Terminated
- August 27, 2014
- Product code
- JGQ – Turbidimetric, Total Protein
- Quantity
- 3395
- Distribution
- 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE