Optilite Analyser (2020-04-09)
- Starting date:
- April 9, 2020
- Posting date:
- May 1, 2020
- 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-72943
Last updated: 2020-05-01
Affected Products
Optilite Analyser
Reason
A software issue has been identified which may affect Optilite Analysers running software versions 7.0 Or 7.0.1. The software bug is not assay specific and if it occurs, it may cause a result to be calculated against a previously validated, although historical calibration curve for the affected assay.
Affected products
Optilite Analyser
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- IE700
Companies
- Manufacturer
-
The Binding Site Group Limited
8 Calthorpe Road
Birmingham
B15 1QT
UNITED KINGDOM