Recall Z-1578-2016 ยท JJH Clinical Sample Concentrator
Roche Molecular Systems, Inc.
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
| Date | Apr 27, 2016 (initiated Mar 3, 2016) |
| Status | Terminated |
| Reason | The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID. |
| Root cause | Labeling design |
| 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. |
| Quantity | 6,939 pieces |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.