Recall Z-2013-2012 · JQW Station, Pipetting And Diluting, For Clinical Use

Abbott Molecular

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 posi

Date	Jul 14, 2012 (initiated Jan 31, 2012)
Status	Terminated
Reason	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
Root cause	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 implement
Quantity	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
FDA record	Open on fda.gov

510(k) clearances named in this recall

K092705

ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
Abbott Molecular, Inc., May 28, 2010