Vitros 5600 and 4600 Integrated System (2014-09-09)

Starting date:

September 9, 2014

Posting date:

September 22, 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, Healthcare Professionals, Hospitals

Identification number:

RA-41399

• 
  Reason
• 
  Affected products

Recalled products

A) Vitros 5600 Integrated System (Licence #78571)

B) Vitros 5600 Integrated System (Licence #80701)

C) Vitros 4600 Integrated System

Reason

Ortho Clinical Diagnostics (OCD) has identified an anomaly with Vitros system software version 3.0 and below. Internal testing confirmed that when using calibrator barcode labels supplied with Vitros chemistry products calibrator kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned. Consignees are being instructed not to use the calibrator barcode labels for Vitros calibrator kits 1, 2, 3, 4, 6, or 9 until the next version of software is installed on their Vitros system.

Affected products