Elecsys Anti-TSHR (2018-08-21)

Starting date:

August 21, 2018

Posting date:

January 11, 2019

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-68734

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  Reason
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  Affected products

Affected products

Elecsys Anti-TSHR

Reason

Following internal investigation of customer complaints, the manufacturer confirmed a limitation in On-Board Stability (OBS) of the product Elecsys Anti-TSHR (#07026951190) lot #28356401 used on cobas e 801 module. The OBS could be maintained for 8 weeks, in comparison to the 16 weeks OBS claim as described in the Method Sheet of the assay.

Affected products