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CELLTRACKS ANALYZER II
MENARINI SILICON BIOSYSTEMS, INC. · Model 9555 · UDI-DI 10888385000658
NQI
Prescription
1
510(k) clearances
3
Adverse events
9
Recalls
3
Facilities
Description
CELLTRACKS ANALYZER II - EU ROHS Compliant
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 some patient samples |
| 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 in reporting the resu |
| 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 as well as the failur |
| 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 this notification i |
| 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 this notification i |
| 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 Analyzer II. |
| 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 Circulating Tumor Cell |
| 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. |
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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.