Elecsys Troponin T HS (2019-11-28)

Starting date:

November 28, 2019

Posting date:

December 13, 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-71877

Last updated: 2019-12-13

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  Reason
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  Affected products

Affected Products

Elecsys Troponin T HS

Reason

Our manufacturer confirmed that, in rare cases, non-reproducible elevated results may be obtained with the Elecsys Troponin T HS reagent of lot number 429178 used on cobas E 801 instrument.

Affected products