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Leica Biosystems Ariol Camera Large, Jai CVM2
Leica Biosystems Richmond, Inc. · Model 23ACM2 · UDI-DI 00849832007883
NQN
Prescription
10
510(k) clearances
5
Adverse events
4
Recalls
2
Facilities
Description
Leica Biosystems Ariol Camera Large, Jai CVM2
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-11-23 | Roche Molecular Systems, Inc. | When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "S |
| 2016-05-06 | Leica Biosystems Richmond Inc. | An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured s |
| 2008-11-06 | Leica Microsystems, Inc. | A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval. |
| 2007-06-26 | Ventana Medical Systems Inc | Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software upgrade adds the algorithm (Slidetype) for the PATHWAY anti-HER-2/neu (4B |
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