This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Specimen Gate Laboratory
- Starting date:
- July 7, 2017
- Posting date:
- August 14, 2017
- 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-64164
Reason
The deployed specimen gate laboratory software is not functioning consistent with the configured parameters defined by the customer. The issue may result in reporting incorrect results.
Affected products
Specimen Gate Laboratory
Lot or serial number
Software Rev. 1.9
Model or catalog number
5002-0180
Companies
- Manufacturer
-
Wallac Oy
Mustionkatu 6, P.O. Box 10
Turku
20750
FINLAND