| Date Initiated by Firm |
March 03, 2016 |
| Date Posted |
April 27, 2016 |
| Recall Status1 |
Terminated 3 on May 25, 2017 |
| Recall Number |
Z-1578-2016 |
| Recall Event ID |
73680 |
| Product Classification |
Clinical sample concentrator - Product Code JJH
|
| Product |
Hand-Held Scanner USB IT3800
For sample identification and tracking when used with various systems |
| Code Information |
Material Number - IVD: 5401062001 |
Recalling Firm/
Manufacturer |
Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
|
| For Additional Information Contact |
908-253-7200
|
Manufacturer Reason
for Recall |
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
|
FDA Determined
Cause 2 |
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 in Commerce |
6,939 pieces |
| Distribution |
Nationwide Distribution |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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