ASSAYED CHEMISTRY CONTROL PREMIUM PLUS (2019-07-23)

Starting date:

July 23, 2019

Posting date:

August 2, 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-70611

Last updated: 2019-08-02

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  Reason
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  Affected products

Affected Products

ASSAYED CHEMISTRY CONTROL PREMIUM PLUS

Reason

Randox have realigned the RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target from calibrator lot 961UE onwards. No other instruments are affected. The target and range for the associated Quality Control Material has been revised to align with this change. Updated RX control targets are available at randox.com.

Affected products