Recall Z-1578-2016— Roche Molecular Systems, Inc.

Name: FDA recall Z-1578-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-03

Class II · Terminated

Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2016-03-03, terminated 2017-05-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems. Reason: The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID..

Recalling firm: Roche Molecular Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-03
Terminated: 2017-05-25
Firm location: Branchburg, NJ, United States

Product description

Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

Reason for recall

The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.

Data sourced from openFDA. This site is unofficial and independent of the FDA.