Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
This recall has been terminated (originally issued April 27, 2016).
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- March 3, 2016
- Posted
- April 27, 2016
- Terminated
- May 25, 2017
- Recall Number
- Z-1578-2016
- Quantity
- 6,939 pieces
- Firm Location
- Branchburg, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
Distribution
Nationwide Distribution
Lot / Code Info
Material Number - IVD: 5401062001
Root Cause
Labeling design
Action Taken
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.