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Stainer, Tissue, Automated
FDA product code KEY · Class 1 · Pathology
19
Registered devices
24
Adverse events
5
Recalls
1
510(k) clearances
Devices with this code
Millennium — Avalign Technologies, Inc.Xmatrx® MINI — BIOGENEX LABORATORIESi6000™ Diagnostics — BIOGENEX LABORATORIESVP2000 — ABBOTT MOLECULAR INC.VP2000 — ABBOTT MOLECULAR INC.VP2000 — ABBOTT MOLECULAR INC.i6000™ Infinity — BIOGENEX LABORATORIESVP2000 — ABBOTT MOLECULAR INC.NanoVIP® — BIOGENEX LABORATORIESMillennium — Avalign Technologies, Inc.Xmatrx® Infinity — BIOGENEX LABORATORIESXmatrx® Elite — BIOGENEX LABORATORIESVP2000 — ABBOTT MOLECULAR INC.Xmatrx® Nano — BIOGENEX LABORATORIESVP2000 — ABBOTT MOLECULAR INC.VP2000 — ABBOTT MOLECULAR INC.VP2000 — ABBOTT MOLECULAR INC.VP2000 — ABBOTT MOLECULAR INC.VP2000 — ABBOTT MOLECULAR INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-01-23 | Biogenex Laboratories | Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution. |
| 2008-09-15 | Abbott Molecular | Thermal runaway conditions, in that the target temperature was exceeded and the temperature display could not track the actual temperature within the heated sli |
| 2008-01-24 | Biogenex Laboratories | Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals. |
| 2007-10-30 | Ventana Medical Systems Inc | Fluid Leaks-The T fitting located in the Symphony Clear system of the Symphony High Volume Slide Stainer needs to be larger to securely hold the tubing in place |
| 2007-09-06 | Ventana Medical Systems Inc | Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate |
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