Home › Device types › NQI
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
FDA product code NQI · Class 2 · Immunology
10
Registered devices
3
Adverse events
9
Recalls
13
510(k) clearances
Devices with this code
CELLTRACKS ANALYZER II — MENARINI SILICON BIOSYSTEMS, INC.CELLTRACKS AUTOPREP — MENARINI SILICON BIOSYSTEMS, INC.CELLTRACKS AUTOPREP — MENARINI SILICON BIOSYSTEMS, INC.CELLTRACKS ANALYZER II — MENARINI SILICON BIOSYSTEMS, INC.CELLTRACKS AUTOPREP — MENARINI SILICON BIOSYSTEMS, INC.CELLTRACKS ANALYZER II — MENARINI SILICON BIOSYSTEMS, INC.CELLTRACKS ANALYZER II — MENARINI SILICON BIOSYSTEMS, INC.CELLTRACKS AUTOPREP — MENARINI SILICON BIOSYSTEMS, INC.Care One — Ahold U.S.A., Inc.CellSearch — MENARINI SILICON BIOSYSTEMS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-20 | Menarini Silicon Biosystems | High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in som |
| 2018-04-04 | Menarini Silicon Biosystems | Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay i |
| 2015-05-15 | Veridex, LLC | Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples a |
| 2014-01-08 | Veridex, LLC | Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II. |
| 2012-12-28 | Veridex, LLC | Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of |
| 2012-12-28 | Veridex, LLC | Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of |
| 2011-08-17 | Veridex, LLC | Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyz |
| 2009-08-12 | Veridex, LLC | Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Cir |
| 2007-04-17 | Veridex, LLC | An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.