This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

ORTHO VISION Analyzer (2015-12-10)

Starting date:
December 10, 2015
Posting date:
January 18, 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-56674

Affected Products

A. ORTHO VISION Analyzer

Reason

Ortho Clinical Diagnostics (Ortho) has identified that under specific circumstances, the saline supply on the Ortho vision analyzer may be insufficient to process tests, without operator knowledge.

If an operator opens the liquid access door for any reason, the system software automatically resets, assuming the saline container was refilled to the maximum volume of 4700 ml, regardless of whether the operator refills the saline container or not. If an operator opens the liquid access door and does not refill the saline container to 4700 ml, the system loses track of the actual onboard saline volume. Therefore, the system can no longer accurately determine low saline volume levels and alert the operator.

Affected products

A. ORTHO VISION Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

6904577

Companies
Manufacturer
ORTHO-CLINICAL DIAGNOSTICS INC.
1001 US HWY 202
Raritan
08869
New Jersey
UNITED STATES