AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics
FDA device recall Z-0734-2007 · posted 2007-04-11 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NTI
- Quantity affected
- 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
- Date initiated
- 2007-03-09
- Date posted
- 2007-04-11
- Date terminated
- 2007-08-23
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCHE AMPLICHIP CYP450 TEST (K043576) | Roche Molecular Systems, Inc. | 2005-01-10 |