Date Initiated by Firm | April 23, 2012 |
Date Posted | September 18, 2012 |
Recall Status1 |
Terminated 3 on February 12, 2014 |
Recall Number | Z-2403-2012 |
Recall Event ID |
62738 |
Product Classification |
Blood establishment computer software, user developed - Product Code OYT
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Product | Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System. |
Code Information |
05666678001 |
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 | When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order. |
FDA Determined Cause 2 | Device Design |
Action | Roche Molecular Systems Inc. sent "Urgent Field Safety Notice" letters and Faxback forms on 4/23/2012 via UPS to all affected customers. The issue was described and recommended actions were provided. A Product Advisory Notice and an Updated Field Safety Notice were issued as well. |
Quantity in Commerce | 1292 instruments |
Distribution | Nationwide (USA) Distribution |
Total Product Life Cycle | TPLC Device Report |
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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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