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U.S. Department of Health and Human Services

Class 2 Device Recall Roche

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  Class 2 Device Recall Roche see related information
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/
Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
For Additional Information Contact
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.