Vitros Chemistry Systems

Starting date:

May 6, 2013

Posting date:

July 23, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-34183

• Reason
• Affected products

Recalled products

1. Vitros 5,1 Chemistry System
2. Vitros 5600 Integrated System
3. Vitros 4600 Chemistry System

Reason

OCD has issued a recall pertaining to a potential malfunction in a wire connector used in the Vitros 4600, Vitros 5600 and Vitros 5,1 FS systems that were shipped during a specific date range. To date, six customers reported the smell of melting plastic or observed smoke originating from their Vitros 4600 and 5600 systems. Although reports are confined to the Vitros 4600 and 5600 systems, the same wire connector is also used on Vitros 5,1 FS systems. As a precaution, OCD is contacting customers to notify them of this potential malfunction for Vitros systems that were shipped during a specific date range.

Affected products