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Terminated

Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System

FDA Recall Z-1535-2010 · Posted 2010-05-04

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIX
Date Initiated2009-10-23
Date Terminated2010-06-22
Product Quantity1753 cartons

Reason for Recall

patient results are depressed

Firm Action

An "Urgent Field Safety Notice" dated October 2009 was issued by Siemens to all customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to recalibrate the AMON method (AMON Flex reagent cartridge, K3019) with Vista Chem 3 Claibrator lot 9ED058 using the revised bottle values provided in the notice and to please consult with their laboratory director regarding re-evaluation of previous results. The customers should forward this notification to anyone to whom they may have distributed this product. If you have any technical questions regarding this information, please contact Siemens Technical Solutions Center at 1-800-441-9250.

Root Cause

Other

Distribution Pattern

Worldwide distribution: USA and Australia, Canada, Japan, New Zealand, South Korea, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062334DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130Dade Behring, Inc. · 2006-09-22

Official Source

View FDA Recall →

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

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