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Terminated

Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid. Vista (TM) system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.

FDA Recall Z-0031-2012 · Posted 2011-10-07

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2011-08-08
Date Terminated2013-12-24
Product Quantity1,786

Reason for Recall

Siemens Healthcare Diagnostics has confirmed a low frequency defect in the molding of the Cuvettes that may result in Cuvette Ring and Cuvette Loader jams. It has been determined that the issue is related to a molding defect with the Cuvette flange or "wing" breaking, resulting in an error condition. Therefore, patient results are not impacted.

Firm Action

Siemens Healthcare Diagnostics sent a Urgent Field Safety Notice letter dated August 2011, to all affected customers. The letter identifed the product the problem and the action needed to be taken by customer. Customers were instructed to discard all cuvette cartridges of the identified lots. Customers were also informed that until a replacement lot is available, if an error is encountered, they may contact the Technical Solutions Center for assistance at (800) 441-9245. For replacement product , please call the Siemens Atlanta Customer Service Center at (800) 241-0420.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and Puerto Rico., and the countries of Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Spain, Switzerland, Australia, Japan, South Korea, and Canada.

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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