Health product recall

Homocysteine Calibrator (2018-02-22)

Starting date:
February 22, 2018
Posting date:
March 13, 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-66132

Affected products

HOMOCYSTEINE CALIBRATOR

Reason

The Homocysteine Calibrator Kit may cause up to 20% higher recoveries in quality control and patient samples. False results are detected in the control but may cause delay in obtaining results.

Affected products

HOMOCYSTEINE CALIBRATOR

Lot or serial number

235108

Model or catalog number

5385504190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY