Access hsTnI Reagent (2018-10-15)

Starting date:

October 15, 2018

Posting date:

November 28, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68382

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  Reason
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  Affected products

Affected products

Access hsTnI Reagent

Reason

The Cardiac Troponin T Cross Reactivity concentration of 253 ng/ml (253,000 pg/ml) previously listed in the access HSTNI Instructions For Use (IFU) does not apply to samples with HSTNI concentrations less than 16 pg/ml (ng/l).

Samples containing cardiac troponin t concentrations > 125 ng/ml (125,000 pg/ml) may cross react with the access HSTNI assay:

• access HSTNI results may change by more than 10% for HSTNI sample concentrations greater than 11.5 pg/ml (ng/l);
• access HSTNI results may change by more than 2.30 pg/ml (ng/l) for HSTNI sample concentrations less than or equal to 11.5 pg/ml (ng/l).

Affected products