—#85268

Product

Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System

FDA product code: JIX — Calibrator, Multi-Analyte Mixture
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K061838
Affected lot / code info: Lot Number 9DM001

Why it was recalled

Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001.

Root cause (FDA determination)

Other

Action the firm took

An Urgent Field Safety Notice dated August 31, 2009, was issued to all affected customers. Customers were instructed to discontinue the use of Dimension Vista System CHEM 1 Cal lot 9DM001 and discard any remaining product. If customers have any question they can contact Technical Solutions at 1-800-241-0420.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Foreign: Australia, Canada, Denmark, and Malaysia.

Timeline

Recall initiated: 2009-08-31
Posted by FDA: 2010-02-26
Terminated: 2010-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85268. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.