Access hsTnI (2020-04-08)

Starting date:

April 8, 2020

Posting date:

May 8, 2020

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-72997

Last updated: 2020-05-08

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  Reason
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  Affected products

Affected Products

Access hsTnI

Reason

Beckman Coulter has determined through customer feedback and an internal investigation that testing a sample with cardiac troponin I (CTNI) concentrations that are > 270,000 pg/ml (ng/L) may cause carryover into the hsTnI reagent pack.

Affected products