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U.S. Department of Health and Human Services

Class 2 Device Recall Amplilink

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  Class 2 Device Recall Amplilink see related information
Date Initiated by Firm May 21, 2007
Date Posted August 02, 2007
Recall Status1 Terminated 3 on February 18, 2010
Recall Number Z-1106-2007
Recall Event ID 37963
510(K)Number K964506  
Product Classification in vitro diagnostic - Product Code JJF
Product Amplilink Software versions 1.1, 1.3, 1.4, 2.41.
COBAS Amplicor CTA & NGA Tests
Code Information Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122, 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 2		 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.
510(K) Database 510(K)s with Product Code = JJF and Original Applicant = ROCHE MOLECULAR SYSTEMS, INC.
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