ORTHO VISION Analyzer (2016-02-25)

Starting date:

February 25, 2016

Posting date:

March 10, 2016

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-57474

• Reason
• Affected products

Affected Products

1. ORTHO VISION Analyzer

Reason

Ortho Clinical Diagnostics (Ortho) is issuing this recall due to an unlikely scenario in which a user inappropriately removes or interchanges samples in an onboard sample rack or removes an onboard dilution tray after making a reagents load/unload request. If an unexpected change is made in a load station location that was not selected via the Graphical User Interface (GUI), the system will not detect the change.

If users deviate from normal process for changing patient samples, the analyzer may not detect the change. In this case, samples can be associated with another sample ID, which can potentially lead to erroneous test results being reported. This issue was identified internally by Ortho. To date, Ortho has received no customer complaints or reports of patient injury due to this issue.

Affected products