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Axsym System - Valproic Acid Assay (2013-10-31)
- Starting date:
- October 31, 2013
- Posting date:
- December 4, 2013
- 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-36983
Recalled products
A. Axsym System - Valproic Acid Assay
Reason
Abbott has confirmed that some kits of Axsym Valproic Acid Reagent lot 18439M503 have the potential to generate invalid calibration, control or sample runs due to net intensity too low, resulting in axsym instrument error code 1072. If the error occurs during calibration, the curve will be invalid and recalibration will be required. If the error occurs during a control/sample run, no results will be reported.
Affected products
A. Axsym System - Valproic Acid Assay
Lot or serial number
- 18439M503
Model or catalog number
- 7A71-20
Companies
- Manufacturer
-
Abbott Laboratories Diagnostcis Division
100 Abbott Park Road,
Abbot Park
60064
Illinois
UNITED STATES