Hypercoagulation Panel (HC) Sample Buffer
NANOSPHERE, INC. · Model 30-001-001 · UDI-DI 00857573006348
Description
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
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, Switzerland, after receiv |
| 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 2.0 Instrument in the |
| 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 data repository of the |
| 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 potential sample contamina |
| 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 been decontaminated |
| 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 been decontaminated |
| 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 been decontaminate |
| 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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