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Test, Factor V Leiden Mutations, Genomic Dna Pcr
FDA product code NPQ · Class 2 · Hematology
16
Registered devices
25
Adverse events
14
Recalls
6
510(k) clearances
Devices with this code
INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine — AUTOGENOMICS, INCINFINITI® Factor II-V Leiden Intellipac® Reagent Module — AUTOGENOMICS, INCHypercoagulation Panel (HC) Nucleic Acid Test Cartridge — LUMINEX CORPORATIONINVADER — Hologic, Inc.INFINITI® Factor II-V Leiden Amplification Mix — AUTOGENOMICS, INCINFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine — AUTOGENOMICS, INCXpert HemosIL FII & FV — CEPHEIDHypercoagulation Panel (HC) Sample Buffer — LUMINEX CORPORATIONHypercoagulation Panel (HC) Nucleic Acid Test Cartridge — NANOSPHERE, INC.Hypercoagulation Panel (HC) Sample Buffer — NANOSPHERE, INC.INFINITI® Factor V Leiden Amplification Mix — AUTOGENOMICS, INCFactor V Leiden Kit — Roche Diagnostics GmbHINVADER — Hologic, Inc.INFINITI® Factor V Leiden Intellipac® Reagent Module — AUTOGENOMICS, INCXpert Factor II & Factor V — CEPHEIDcobas Factor II and Factor V Test — Roche Molecular Systems, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-09-04 | Zimmer, Inc. | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switz |
| 2011-03-31 | Roche Molecular Systems, Inc. | 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 |
| 2010-10-26 | Roche Diagnostics Operations, Inc. | 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 dat |
| 2008-11-07 | Synthes Spine | the dimensional specifications are incorrect |
| 2008-11-07 | Synthes Spine | the dimensional specifications are incorrect |
| 2007-05-14 | Roche Diagnostics Corp. | 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 potent |
| 2006-07-17 | Roche Diagnostics Corp. | 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 |
| 2006-07-17 | Roche Diagnostics Corp. | 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 |
| 2006-07-17 | Roche Diagnostics Corp. | 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 ha |
| 2006-04-04 | Roche Diagnostics Corp. | The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument. |
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