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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Molecular Bar Code Scanner User's Guide

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 Class 2 Recall
Abbott Molecular Bar Code Scanner User's Guide
see related information
Date Posted July 14, 2012
Recall Status1 Terminated on December 04, 2012
Recall Number Z-2013-2012
Recall Event ID 62329
Premarket Notification
510(K) Number
K092705 
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
Product 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.
Code Information list numbers 06L88-02, 06L88-03, 06L88-04, 06L88-05, 06L88-06, 06L88-07, 06L88-08 and 06L88-09, all lots
Recalling Firm/
Manufacturer
Abbott Molecular
1300 E Touhy Ave
Des Plaines, Illinois 60018-3315
Manufacturer 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 Ab
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Abbott Molecular Inc. sent an Urgent Field Safety Notice letter dated January 31, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to replace the affected pages of the Bar Code Scanner User's Guide with the replacement pages provided with the letter, and immediately perform the Modifying the Keyboard Format section with these replacement pages. The accounts were requested to complete the enclosed reply form and fax it to (847) 775-6728 to acknowledge receipt, understanding and implementation of the information provided in the notice.
Quantity in Commerce 100 units
Distribution California, Florida, Maryland, Oregon and Virginia, and internationally to Belgium, Brazil, China, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Qatar, Switzerland and United Kingdom
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JQW and Original Applicant = ABBOTT MOLECULAR, INC.
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