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Millennium
Avalign Technologies, Inc. · Model 1-T1436 · UDI-DI 00190776184483
KEY
Prescription
1
510(k) clearances
24
Adverse events
5
Recalls
13
Facilities
Description
CUST FINE DOUBLE MESH STRAINER DIAMETER
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 slide basins of the VP |
| 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 to eliminate any po |
| 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 all components in th |
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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.