AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.
FDA device recall Z-0735-2007 · 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
- 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
- Date initiated
- 2007-03-09
- Date posted
- 2007-04-11
- Date terminated
- 2007-08-23
- Location
- Somerville, NJ
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