Unicel DXI 600 and DXI 800 Access Immunoassay Systems (2014-01-29)

Starting date:

January 29, 2014

Posting date:

March 18, 2014

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-38327

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  Reason
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  Affected products

Recalled Products

Unicel DXI 600 and DXI 800 Access Immunoassay Systems

Reason

The Access Thyroglobulin Calibrators are a lyophilized product and as such need to be reconstituted prior to use. The reconstitution time of 30 minutes as stated in the thyroglobulin calibrators instructions for use (IFU) is insufficient for the four affected lots of thyroglobulin calibrators. This has resulted in high patient and control results that are on average greater than 1 standard deviation high.

Affected products