Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cere

FDA device recall Z-0017-2014 · posted 2013-10-17 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

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.

Root cause

Process control

Status

Terminated

Product code

JGQ

Quantity affected

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,

Date initiated

2012-12-19

Date posted

2013-10-17

Date terminated

2014-08-27

Location

Newark, DE