Vitros 5.1 FS, 5600, and 4600 Systems (June 07, 2013)

Starting date:

June 07, 2013

Posting date:

June 07, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-34985

• Reason
• Affected products

Reason

Ortho-Clinical Diagnostics has announced a recall to inform customers of a change to the frequency of replacement for the CM/RT wear pads on Vitros 5600, 4600 and 5,1 FS systems.

CM/RT wear pads are a component in the CM/RT incubator. The CM/RT rotor revolves on three wear pads within the incubator. By design, there is a small gap between the rotor and the hot plate to allow for the transfer of heat. If the wear pads become too thin, it may cause the rotor to rub on the hot plate resulting in black dust within the incubator.

The impact of black dust may contribute to unplanned system down time. We have no data that suggests that black dust has any adverse effect on results.

Affected products