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U.S. Department of Health and Human Services

Class 2 Device Recall AmpliChip CYP450

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 Class 2 Recall
AmpliChip CYP450
see related information
Date Posted April 11, 2007
Recall Status1 Terminated on August 23, 2007
Recall Number Z-0735-2007
Recall Event ID 37585
Premarket Notification
510(K) Numbers
K042259  K043576 
Product Classification Drug Metabolizing Enzyme Genotyping Systems - Product Code NTI
Product AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.
Code Information European Distribution: Model number 4381866190 (CE-IVD) Batches: H08500, H13591, H14242, J00383, J00814
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 US Highway 202 S
Somerville, New Jersey 08876-3733
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Vincent C. Stagnitto
908-253-7569
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
MISBRANDING: Labeling False and Misleading
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 89
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NTI and Original Applicant = ROCHE MOLECULAR SYSTEMS, INC.
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