| Class 2 Device Recall AMPLILINK | |
Date Initiated by Firm | July 16, 2012 |
Date Posted | December 07, 2012 |
Recall Status1 |
Terminated 3 on July 22, 2015 |
Recall Number | Z-0484-2013 |
Recall Event ID |
63312 |
Product Classification |
Software, transmission and storage, patient data - Product Code NSX
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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 NJ 08876-3733
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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 | 884 units |
Distribution | Nationwide Distribution |
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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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