Class 2 Device Recall Amplilink

• Date Initiated by Firm: May 21, 2007
• Date Posted: August 02, 2007
• Recall Status: Terminated on February 18, 2010
• Recall Number: Z-1107-2007
• Recall Event ID: 37963
• PMA Number: P000012S003
• Product Classification: in vitro diagnostic - Product Code MZP
• Product: Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0
• Code Information: Catalog number 03576710190, working substrate SB3-SB
• Recalling Firm/ Manufacturer: Roche Molecular Systems, Inc.; 1080 US Highway 202 S; Somerville NJ 08876-3733
• For Additional Information Contact: Vincent Stagnitto; 908-253-7885
• Manufacturer Reason for Recall: For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions 1.1, 1.3, 1.4 and 2.41) and the stability information provided in the test kit package inserts/method manual.
• FDA Determined Cause: Other
• Action: Urgent Medical Device Correction letters were mailed on 5/21/07 by first class mail. Letters describe the discrepancy between software reagent expiration dates and package insert expiration dates.
• Quantity in Commerce: 5,806 total
• Distribution: Nationwide to hospitals and laboratories.
• 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.

• PMA Database: PMAs with Product Code = MZP