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Class 2 Device Recall AmpliChip CYP450 |
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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
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Product Classification |
Drug Metabolizing Enzyme Genotyping System - Product Code NTI
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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/ Manufacturer |
Roche Molecular Systems, Inc. 1080 US Highway 202 S Somerville NJ 08876-3733
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For Additional Information Contact |
Vincent C. Stagnitto 908-253-7569
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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.
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FDA Determined Cause 2 |
Other |
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
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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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510(K) Database |
510(K)s with Product Code = NTI and Original Applicant = ROCHE MOLECULAR SYSTEMS, INC.
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