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U.S. Department of Health and Human Services

Class 2 Device Recall AMPLILINK

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 Class 2 Recall
AMPLILINK
see related information
Date Posted December 07, 2012
Recall Status1 Open
Recall Number Z-0484-2013
Recall Event ID 63312
Premarket Notification
510(K) Number
K012966 
Product Classification Software, Transmission And Storage, Patient Data - Product Code NSX
Product Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS® AmpliPrep instrument, COBAS® TaqMan® analyzer, COBAS® TaqMan® 48 analyzer, COBAS® AMPLICOR® analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
Code Information Device-associated diagnostic software
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg, New Jersey 08876-3733
For Additional Information Contact Mr. Vincent Stagnitto
908-253-7569
Manufacturer Reason
for Recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
FDA Determined
Cause 2
DESIGN: Software Design
Action Roche sent an "Urgent Medical Device Correction" (UMDC) notification letter dated July 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Molecular Systems, Inc. has disabled this software on affected Roche platforms and discontinued the distribution of the affected software. Contact Roche Diagnostic Technical Support, 24 hours a day, seven days a week at phone number : 1-800-428-2336 if you have questions regarding this notification. For questions regarding this recall call 908-253-7569.
Quantity in Commerce 884 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NSX and Original Applicant = ROCHE MOLECULAR SYSTEMS, INC.
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