Vitros System (2014-07-07)

Starting date:

July 7, 2014

Posting date:

July 25, 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-40681

• 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

OCD has identified an anomaly with Vitros system software version 3.0 & below on the Vitros 3600 immunodiagnostic system, Vitros 4600 chemistry system, and Vitros 5600 integrated system. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number. This issue may occur when condition code PY1-075 is generated for a sample ID and the operator does not follow the instructions provided below in the condition review in V-docs.

Affected products