Medical Device Recall: Z-0017-2014

FDA Recalls dataset · Firm: Siemens Healthcare Diagnostics, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2012-12-19 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0017-2014.

Recall Res Number
Z-0017-2014
Recalling Firm / Manufacturer
Siemens Healthcare Diagnostics, Inc.
FEI Number
2517506
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2012-12-19
Date Posted
2013-10-17
Date Terminated
2014-08-27
Product Code
JGQ
Event Number
64808
Product Quantity
3395
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.
Action Details 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.
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.
Code Information / Serial Numbers Lot No. 11349BB

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