—#106124

Product

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 product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K051087
Affected lot / code info: Lot number KE1H01, KE1J01, and KE1K01

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

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.

Timeline

Recall initiated: 2011-10-31
Posted by FDA: 2012-01-11
Terminated: 2013-12-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106124. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.