Test, Factor V Leiden Mutations, Genomic Dna Pcr
Hematology · 21 CFR 864.7280
In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Recent MDR events
25 adverse event reports on file
- COBAS® FACTOR II AND FACTOR V TESTMar 26, 2026MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2026-01104
- COBAS® FACTOR II AND FACTOR V TESTJan 6, 2026MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2026-00061
- INVADER FACTOR VDec 28, 2017InjuryHologic, Inc2024800-2017-00028
- ILLUMINA TEST KITAug 15, 2017InjuryIllumina Inc.MW5071604
- VERIGENE F2 NUCLEIC ACID TESTJun 12, 2013OtherNanosphere Inc.(nsph)3006028115-2013-00001
- ONCOTYPE DXMay 31, 2011InjuryGenomic HealthMW5020846
- ONCOTYPE DX MULTIVARIATE INDEXMay 27, 2011InjuryGenomic HealthMW5020796
- ONCOTYPE DX MULTIVARIATE INDEXMay 27, 2011InjuryGenomic HealthMW5020797
- ONCOTYPE DX MULTIVARIATE INDEXMay 27, 2011InjuryGenomic HealthMW5020800
- ONCOTYPE DX MULTIVARIATE INDEXMay 27, 2011InjuryGenomic HealthMW5020798
Event type breakdown
Recalls
14 recall events for this product code
- Zimmer, Inc.TerminatedNov 6, 2012
Dynesys L.I.S. Stabilizing cord
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Z-0238-2013 · View FDA record ↗ - Roche Molecular Systems, Inc.TerminatedJun 14, 2011
Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA; Distributed by Roche Diagnostic
Roche Molecular Systems has decided to discontinue marketing the Factor II (Prothrombin) G20210A Kit and the Factor V Leiden Kit for use with the Light Cycler 2.0 Instrument in the US Market
Z-2566-2011 · View FDA record ↗ - Roche Diagnostics Operations, Inc.TerminatedMar 14, 2011
Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN
If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the data repository of the MPLC 2.0 software. This may result in sample mis identification. If printed from the ordering screens, the bar code is printed with the correct batch ID.
Z-1653-2011 · View FDA record ↗ - Synthes SpineTerminatedFeb 3, 2009
NFlex Stabilization System 200 mm, Catalog number NF60020-1.
the dimensional specifications are incorrect
Z-0967-2009 · View FDA record ↗ - Synthes SpineTerminatedFeb 3, 2009
NFlex Stabilization System 150 mm, Catalog number NF60150-1.
the dimensional specifications are incorrect
Z-0968-2009 · View FDA record ↗ - Roche Diagnostics Corp.TerminatedJun 22, 2007
MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.
False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined that a potential sample contamination may not be detected at these levels and could result in false positive results being reported.
Z-0956-2007 · View FDA record ↗ - Roche Diagnostics Corp.TerminatedAug 5, 2006
Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembl
If the user opens the instrument lid during decontamination, the cycle will stop, but the timer will continue, resulting in the user believing the instrument has been decontaminated when it has not .
Z-1372-06 · View FDA record ↗ - Roche Diagnostics Corp.TerminatedAug 5, 2006
Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and assem
If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not been.
Z-1373-06 · View FDA record ↗ - Roche Diagnostics Corp.TerminatedAug 5, 2006
Roche MagNA Pure LC Instrument; Catalog nos. 12236931444, 12236931692 ( Refurbished) and 12236931690 (Return). An automated, general purpose instrument for iso
If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not been.
Z-1374-06 · View FDA record ↗ - Roche Diagnostics Corp.TerminatedApr 19, 2006
Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog num
The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.
Z-0774-06 · View FDA record ↗
Registered firms
10 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Hologic, Inc.Jun 1, 2011
K100980 · INVADER FACTOR V
- Illumina, Inc.Apr 28, 2010
K093129 · ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
- Osmetech Molecular DiagnosticsApr 22, 2010
K093974 · ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
- CepheidSep 18, 2009
K082118 · XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
- AutoGenomics, Inc.Feb 7, 2007
K060564 · INFINITI SYSTEM
- Roche Diagnostics Corp.Dec 17, 2003
DEN030005 · FACTOR V LEIDEN KIT