Liquid Cardiac Controls Troponin T (2018-10-04)

Starting date:

October 4, 2018

Posting date:

October 26, 2018

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-68096

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  Reason
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  Affected products

Affected products

Liquid Cardiac Controls Troponin T

Reason

Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on the 08 June 2018. We have now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 AND CQ5053 are no longer suitable for the control of the troponin T assay due to unacceptable variation between vial.

Affected products