Elecsys Anti-HBs II (2019-11-18)

Starting date:

November 18, 2019

Posting date:

December 6, 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-71814

Last updated: 2019-12-06

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  Reason
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  Affected products

Affected Products

Elecsys Anti‑HBs II

Reason

Following a local internal investigation,we would like to inform you of a situation that occurred in shipments to customers of some quantity of the Elecsys Anti-HBs II assay ( Cat # 05894816190 lot 43369003) during the week of 11 Nov 2019 where a potential for exposure to a temperature excursion was identified during manufacturer's transit. The manufacturer confirmed our removal actions on 18-Nov-2019.

Affected products