Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
FDA Recall Z-1578-2016 · Posted 2016-04-27
Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeJJH
Date Initiated2016-03-03
Date Terminated2017-05-25
Product Quantity6,939 pieces
Reason for Recall
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
Firm Action
Roche Molecular Systems sent an "Urgent Medical Device Correction (UMDC) notification letter dated March 3, 2016, to their affected customers. Customers were instructed to provide the UMDC to other affected parties who may need to be aware of this issue. Customers were asked to complete the attached fax form and fax it to 1-866-737-5396. Customers with questions should contact Roche Support Network Customer Support Center at 1-800-526-1247. For questions regarding this recall call 908-253-7200.
Root Cause
Labeling design
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.