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Terminated

Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) Product Usage: V-LYTE(R) Diluent is for the automatic dilution of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension Vista(R) system

FDA Recall Z-0646-2012 · Posted 2012-01-11

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2011-10-31
Date Terminated2013-12-24
Product Quantity5,282

Reason for Recall

Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IMT sensor. The results can be elevated approximately 10-20% which may cause QC recovery being out of acceptable ranges. Patient Urine sodium results may also b

Firm Action

Siemens sent an Urgent Field Safety Notice letter dated October, 2011 to all consignees. The letter identified the product, description of problem, and actions to be taken. Consignees were instructed to replace the affected lots of V-LYTE(R) Fluids with alternate lots if available and recalibrate. If no alternate lots were available they were recommended to replace the V-LYTE(R) Integrated Multisensor every 24 hours or when indicated by QC until the impacted lots were no longer in use. For replacement product consignees were instructed to contact the Siemens Customer Service at 888-588-3916 or your local Siemens Service Center. Consignees were advised to complete and return the enclosed Customer Response Sheet via fax to the Technical Solutions Center at 302-631-8467. For questions or concerns contact Siemens Technical Solutions Center at 800-441-9250 for further assistance.

Root Cause

Material/Component Contamination

Distribution Pattern

Worldwide Distribution - USA (nationwide) iin the states of : AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MS, MO, MT, NE, NH, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, VT, UT, VA, WA, WV, WI, WY including Puerto Rico and Washington, DC and the countries of: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Canada, Australia, Japan, New Zealand, Malaysia, and South Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051087DIMENSION VISTA INTEGRATED SYSTEMDade Behring, Inc. · 2005-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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