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Terminated

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 Recall Z-0864-2010 · Posted 2010-02-26

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIX
Date Initiated2009-08-31
Date Terminated2010-12-13
Product Quantity1474 Cartons

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061838DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110Dade Behring, Inc. · 2006-08-21

Official Source

View FDA Recall →

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

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