Vitros Hand-held Barcode Scanner (accessory to Vitros 3600 Immunodiagnostic System, Vitros 5600 Integrated System, Vitros 5,1 & 4600 Chemistry System) (2014-12-30)

Starting date:

December 30, 2014

Posting date:

January 14, 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-43287

• Reason
• Affected products

Recalled Products

Vitros Hand-held Barcode Scanner (accessory to Vitros 3600 Immunodiagnostic System, Vitros 5600 Integrated System, Vitros 5,1 & 4600 Chemistry System)

Reason

Ortho Clinical Diagnostics (OCD) has received a report that when using a hand-held barcode scanner in combination with use of the batch programming option for programming samples, the scanner unexpectedly skips sample cup positions. For example, a sample tube barcode is scanned for the cup 1 position, the cursor in the batch programming screen skips the cup 2 position and advances to the cup 3 position. If this anomaly occurs, there is a potential for mis-associated results.

Affected products