Health product recall

Elecsys Anti-HAV (2018-11-18)

Starting date:
November 18, 2018
Posting date:
December 10, 2018
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-68546

Affected products

Elecsys Anti-HAV

Reason

Failed calibrations can occur while using all current lots of the Anti-HAV Kit on Immunoassay Analyzers.

Affected products

Elecsys Anti-HAV

Lot or serial number

All lots

Model or catalog number

04854977190
07026757190

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY