Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component

FDA device recall Z-2013-2012 · posted 2012-07-14 · Terminated

Recall details

Recalling firm

Abbott Molecular

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

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

JQW

Quantity affected

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

Date initiated

2012-01-31

Date posted

2012-07-14

Date terminated

2012-12-04

Location

Des Plaines, IL

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