Recall Z-0734-2007 ยท NTI Drug Metabolizing Enzyme Genotyping Systems
Roche Molecular Systems, Inc.
AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics
| Date | Apr 11, 2007 (initiated Mar 9, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043576 | ROCHE AMPLICHIP CYP450 TEST Roche Molecular Systems, Inc., Jan 10, 2005 |