Company: Roche Molecular Systems
Date of Enforcement Report 5/4/2016
Class lI:
PRODUCT
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems. Recall Number Z-1578-2016
REASON
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Branchburg, NJ on 3/3/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6,939 pieces
DISTRIBUTION
Nationwide
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