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GEL Alkaline Phosphatase Isoenzyme Control
- Starting date:
- November 15, 2016
- Posting date:
- November 25, 2016
- 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-61228
Reason
Upon investigation into complaints from customers, Helena Laboratories has confirmed that control values for this lot of GEL Alkaline Phosphatase Isoenzyme Control have fallen outside the acceptable range. When control values fall outside of the acceptable range, the run is considered invalid. Results from an invalid run cannot be reported and the run needs to be repeated.
Affected products
GEL Alkaline Phosphatase Isoenzyme Control
Lot or serial number
1-16-5104
Model or catalog number
5104
Companies
- Manufacturer
-
Helena Laboratories, Inc.
1530 Lindbergh Drive, P.O. Box 752
Beaumont
77704-0752
Texas
UNITED STATES