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Health product recall

Immunoassay Control Premium Plus Level 1

Starting date:: July 24, 2017
Posting date:: September 11, 2017
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-64474

Reason
Affected products

Reason

Randox has confirmed that ACTH in their immunoassay premium plus quality control and immunoassay premium quality control does not meet the quoted reconstituted stability claim in the product IFU. They now recommend that ACTH is to be assayed immediately after the 30-minute reconstitution procedure.

Affected products