Triage Cardio3 Panel (2014-02-15)

Starting date:

February 15, 2014

Posting date:

March 25, 2014

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-38589

• Reason
• Affected products

Recalled Products

Plaque Triage Cardio3

Reason

Alere Triage Cardio 3 lot number W53658B was investigated in response to data observed as part of the routine product performance monitoring program. This lot shows lower than expected results for BNP, CKMB and Troponin I, which in turn could result in an increased rate of false negative results. Testing of external controls would enable your lab to detect if this lot was giving lower than expected results at the time of your testing.

Affected products