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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 CYP450see related information
Date Initiated by FirmMarch 09, 2007
Date PostedApril 11, 2007
Recall Status1 Terminated 3 on August 23, 2007
Recall NumberZ-0734-2007
Recall Event ID 37585
510(K)NumberK043576 
Product Classification Drug Metabolizing Enzyme Genotyping System - Product Code NTI
ProductAmpliChip 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.
FEI Number 2243471
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 US Highway 202 S
Somerville NJ 08876-3733
For Additional Information ContactVincent 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		Other
ActionA 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 Commerce129
DistributionWorld 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 CycleTPLC 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) Database510(K)s with Product Code = NTI
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