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Architect System - Hemoglobin A1C Calibrators(2014-05-02)
- Starting date:
- May 2, 2014
- Posting date:
- May 26, 2014
- 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-39499
Recalled Products
Architect System - Hemoglobin A1C Calibrators
Reason
HBA1C calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HBA1C calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HBA1C assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.
Affected products
Architect System - Hemoglobin A1C Calibrators
Lot or serial number
45063UQ12
Model or catalog number
4P52-02
Companies
- Manufacturer
-
Abbott Laboratories Diagnostcis Division
100 Abbott Park Road,
Abbott Park
60064
Illinois
UNITED STATES