Vitros 3600 and 5600 Immunodiagnostic Systems

Starting date:

May 10, 2013

Posting date:

June 17, 2013

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-34201

• Reason
• Affected products

Recalled products

1. Vitros 3600 Immunodiagnostic System
2. Vitros 5600 Integrated System

Reason

OCD has received several reports of condition codes that occurred during the calibration of Microwell Assays. Internal investigation determined that the Microwell Shuttle Weight on some Vitros systems may be uncoated and, therefore, out of our manufacturing specifications. If an uncoated Microwell Shuttle Weight is installed and calibration of Microwell assays is not performed, biased results could potentially occur. Internal testing determined that quality control results using an uncoated well weight showed, on average, a 10% shift from established means that was within the quality control ranges. The magnitude of the bias is not likely to impact patient safety.

Affected products