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Variant II Beta-Thalassemia Short Program (2014-04-25)
- Starting date:
- April 25, 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-39389
Recalled products
- Variant II Beta-Thalassemia Short Program
Reason
Identification of a problem with the buffer solutions, which change the quantification of the hemoglobin F peak. The calibration and quality control might not meet the standards with the lot that is the subject of this recall.
Affected products
A. Variant II Beta-Thalassemia Short Program
Lot or serial number
Catalogue numbers :
- 270-2103 64005302
- 270-2154 64004750
- 270-2154 64005207
Model or catalog number
- 270-2103
- 270-2154
Companies
- Manufacturer
-
Bio-Rad Laboratories Clinical Diagnostics Group
4000 Alfred Nobel Drive
Hercules
94547
California
UNITED STATES