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U.S. Department of Health and Human Services

Class 2 Device Recall AmpliChip CYP450

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  Class 2 Device Recall AmpliChip CYP450 see related information
Date Initiated by Firm March 09, 2007
Date Posted April 11, 2007
Recall Status1 Terminated 3 on August 23, 2007
Recall Number Z-0734-2007
Recall Event ID 37585
510(K)Number K042259  k043576  
Product Classification Drug Metabolizing Enzyme Genotyping System - Product Code NTI
Product AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics
Code Information US Distribution: Model Number: 4591402190 (US-IVD) Batches: H08499, H10626, H13592, J00807, J00815.
Recalling Firm/
Roche Molecular Systems, Inc.
1080 US Highway 202 S
Somerville NJ 08876-3733
For Additional Information Contact Vincent C. Stagnitto
Manufacturer Reason
for Recall
The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)" . The Part Number listed for the DNase I listed is incorrect and of lower specific activity than the correct/validated DNase.
FDA Determined
Cause 2
Action A product advisory notice was issued on March 9, 2007 to all affiliates, indentifying the problem and listing corrective actions followed by a customer letter (Urgent Medical Device Correction) issued on 3/21/2007, requesting several actions be performed including discontinued use of incorrect DNAse I.
Quantity in Commerce 129
Distribution World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary
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 = NTI and Original Applicant = ROCHE MOLECULAR SYSTEMS, INC.