Z-0017-2014Class II

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

Name: Z-0017-2014 Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-12-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-12-19 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in... on 2012-12-19. FDA classified it as Class II and gives the reason as "Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0017-2014
Classification: Class II
Status: Terminated
Initiated: 2012-12-19
Posted: 2013-10-17
Terminated: 2014-08-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JGQ Turbidimetric, Total Protein
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Lot No. 11349BB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0017-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0017-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-23	2013-10-17

Product code JGQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)