Roche Molecular Systems, Inc. AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics
Brand
Roche Molecular Systems, Inc.
Lot Codes / Batch Numbers
US Distribution: Model Number: 4591402190 (US-IVD) Batches: H08499, H10626, H13592, J00807, J00815.
Products Sold
US Distribution: Model Number: 4591402190 (US-IVD) Batches: H08499, H10626, H13592, J00807, J00815.
Roche Molecular Systems, Inc. is recalling AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics due to 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 Re. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, KY, MI, NC, VA
Page updated: Jan 10, 2026