Vitros Immunodiagnostic, Integrated and Chemistry System (2014-11-20)

Starting date:

November 20, 2014

Posting date:

December 11, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals

Identification number:

RA-42845

• 
  Reason
• 
  Affected products

Recalled Products

A) Vitros 3600 Immunodiagnostic System (Licence # 78572)

B) Vitros 5600 Integrated System (Licence # 78571)

C) Vitros 5600 Integrated System (Licence # 80701)

D) Vitros 3600 Immunodiagnostic System (Licence # 80702)

E) Vitros 4600 Chemistry System

Reason

Ortho Clinical Diagnostics (OCD) has identified an anomaly with Vitros system software version 3.1 and below. OCD determined that the software may not properly identify an expired calibration. Calibration status is monitored by the system software which is based upon the calibration interval and the date of the last calibration. OCD's investigation confirmed that if the anomaly occurs, a calibration may expire, but the system may not alert the operator and not flag results with a CE sample result code (i.e. Calibration expired). The system may unexpectedly generate results even though it is configured to not report results when a calibration has expired.

Affected products