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U.S. Department of Health and Human Services

Class 2 Device Recall LightCycler 2.0

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  Class 2 Device Recall LightCycler 2.0 see related information
Date Initiated by Firm July 16, 2012
Date Posting Updated December 07, 2012
Recall Status1 Terminated 3 on July 22, 2015
Recall Number Z-0488-2013
Recall Event ID 63312
Product Classification Software, transmission and storage, patient data - Product Code NSX
Product LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
Code Information Device-associated diagnostic software
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg NJ 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
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 1,213 units
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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