ORTHO VISION Analyzer (2015-10-07)

Starting date:

October 7, 2015

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-55750

• Reason
• Affected products

Affected Products

ORTHO VISION Analyzer

Reason

Ortho Clinical Diagnostics, Inc. (OCD) initiated this recall due to the potential for used dilution wells to be reused. Reuse of dilution wells can occur if:

• an OCD field engineer performs a clean-up of the analyzer database, or if an operator restores a database backup on the analyzer and,
• dilution trays have not been removed from the instrument prior to restarting the system.

In this situation, the analyzer software cannot identify usage history of the dilution wells on the instrument, and reuse of wells may occur.

Affected products