FDA Device

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 k

Hazard

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

What You Should Do

Remedy

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.

Products

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 6
Brand
Abbott Molecular
UPC
list numbers 06L88-02, 06L88-03, 06L88-04, 06L88-05, 06L88-06, 06L88-07, 06L88-08 and 06L88-09, all lots

Units Affected

100 units