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Z-0031-2012

Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The...

Siemens Healthcare Diagnostics Inc. / initiated 2011-08-08 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0031-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Healthcare Diagnostics Inc.
Product
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.
Product code
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
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.
Quantity in commerce
1,786
Distribution
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.
Product codes and lots
Catalog Number KS850 - lots: X05-076-11, X05-081-11, X05-086-11, X05-090-11, X05-091-11, X05-096-11, X05-101-11, X05-108-11, X05-117-11, X05-122-11, X05-125-11, and X05-126-11.