Stratus CS Acute Care System Cardiac troponin-i TestPak (2019-06-04)

Starting date:

June 4, 2019

Posting date:

June 21, 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-70257

Last updated: 2019-06-21

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  Reason
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  Affected products

Affected Products

Stratus CS Acute Care System Cardiac troponin-i TestPak

Reason

Increased rate of false positive cTnI results beginning 2 months prior to the end of the product's shelf life due to a positive bias and increased imprecision. Increased rate of random non-repeatable false positive cTnI results at any time in the product's shelf life.

Affected products