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IQ Control / Focus Set
- Starting date:
- September 10, 2012
- Posting date:
- December 24, 2012
- 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-25897
Recalled Products
- IQ Control / Focus Set
Reason
The IQ positive control (lot 153-12) which is used to monitor and measure the instrument performance had potential failures. Lot 153-12 had been reported to return low counts of particles.
Affected products
A. IQ Control / Focus Set
Lot or serial number
153-12
Model or catalog number
800-3104
Companies
- Manufacturer
- Iris Diagnostics, a Division of Iris International Inc.