Elecsys Anti-Tg (2019-07-29)

Starting date:

July 29, 2019

Posting date:

August 23, 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-70771

Last updated: 2019-08-23

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  Reason
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  Affected products

Affected Products

Elecsys Anti-Tg

Reason

During a routine internal quality control procedure, a potential performance problem with the Elecsys Anti-Tg of lot number 406816 was identified. This may lead to a significant drop of the calibration signals resulting in low control recoveries. This lot was never distributed to customers in Canada, but since it was imported in Canada, we are issuing this as a manufacturer recall. The manufacturer advised us about this issue on 19-Jul-2019.

Affected products