Z-0734-2007

AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics

Name: Z-0734-2007 AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics
Creator: Roche Molecular Systems, Inc.
Published: 2007-03-09
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2007-03-09 / Terminated / root cause: labeling and UDI

FDA source

Roche Molecular Systems, Inc. began a recall of AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics on 2007-03-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0734-2007
Status: Terminated
Initiated: 2007-03-09
Posted: 2007-04-11
Terminated: 2007-08-23
Recalling firm: Roche Molecular Systems Inc
Product: AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics
Product code: NTI Drug Metabolizing Enzyme Genotyping Systems
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: US Distribution: Model Number: 4591402190 (US-IVD) Batches: H08499, H10626, H13592, J00807, J00815.

Product code NTI

K043576Class IIRoche Amplichip Cyp450 TestRoche Molecular Systems, Inc. / cleared 2005-01-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)