Human Assayed Control Level 2 (2019-05-22)

Starting date:

May 22, 2019

Posting date:

June 7, 2019

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-70131

Last updated: 2019-06-07

• Reason
• Affected products

Affected Products

Human Assayed Control Level 2

Reason

Randox has revised the control ranges for ALT, bicarbonate and gamma-GT in lots 1306UN, 1308UN and 1309UN. The method name for transferrin has also been corrected to state immunoturbidimetric.

Affected products