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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.
Recall Number Z-2013-2012
Classification Class II
Code Info list numbers 06L88-02, 06L88-03, 06L88-04, 06L88-05, 06L88-06, 06L88-07, 06L88-08 and 06L88-09, all lots
Product Distributed Qty 100 units
Reason For Recall In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format. The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the Abbott m2000sp and the Abbott m2000rt instruments.

Event Detail

Event Id 62329
Product Type Devices
Status Ongoing
Recalling Firm Abbott Molecular
City Des Plaines
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-01-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern California, Florida, Maryland, Oregon and Virginia, and internationally to Belgium, Brazil, China, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Qatar, Switzerland and United Kingdom