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TDHisto/Cyto Software (2013-12-09)
- Starting date:
- December 9, 2013
- Posting date:
- March 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38253
Recalled Products
TDHisto/Cyto Software
Reason
For TDHisto/Cyto software versions v11.71.a and higher, there is a risk of sending review requests with "valid" status after a certain sequence of screens (see the communication to users for details). The issue may lead to releasing patient information that has not been clinically validated. This problem only impacts sites using the "screen" validation mode.
Affected products
TDHisto/Cyto Software
Lot or serial number
V. V11.71.A and above
Model or catalog number
TD-TDH-01
Companies
- Manufacturer
-
Technidata S.A.S.
387, Avenue Jean Kuntzmann
Montbonnot Saint Martin
38330
FRANCE