Health product recall

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

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

Elecsys Anti‑HBs II

Lot or serial number

43369003

Model or catalog number

5894816190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY