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IDS-ISYS-Wash system (2014-01-24)
- Starting date:
- January 24, 2014
- Posting date:
- March 20, 2014
- 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-38447
Recalled Products
IDS-ISYS-Wash system
Reason
The ID’s continual quality monitoring program has identified that a very small number of wash solution containers have been manufactured without adding the concentrated solution. The potential hazard associated with the use of the device is an increase in the imprecision and a bias relative to the true concentration of samples measured using the IDS-ISYS assays on board the IDS-ISYS analyser.
Affected products
IDS-ISYS-Wash system
Lot or serial number
IS-CW100
Model or catalog number
75496
76208
Companies
- Manufacturer
-
Immunodiagnostic Systems Limited
10 Didcot Way, Boldon Business Park,
Boldon, Tyne and Wear,
UNITED KINGDOM