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Health product recall

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