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Evidence Investigator
- Starting date:
- September 29, 2016
- Posting date:
- December 16, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61468
Reason
This recall is for a mandatory upgrade in the software to version 2.0.0 to introduce new features and correct some existing features including communication errors, archiving- dilution factor, results reprocessing, and sexually transmitted infection (STI) array.
Affected products
Evidence Investigator
Lot or serial number
- E1-11165
Model or catalog number
- EV3602
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM