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Factor V Leiden Kit
Roche Diagnostics GmbH · Model 1 · UDI-DI 04038377021607
NPQ
Prescription
6
510(k) clearances
25
Adverse events
14
Recalls
4
Facilities
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.