VITROS 5.1 FS CHEMISTRY SYSTEMS ( 2015-06-30)

Starting date:

June 30, 2015

Posting date:

July 21, 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-54314

• Reason
• Affected products

Affected Products

1. VITROS 5,1 FS CHEMISTRY SYSTEM (LICENCE #66236)
2. VITROS 5,1 FS CHEMISTRY SYSTEM (REFURBISHED) (LICENCE #66236)
3. VITROS 5,1 FS CHEMISTRY SYSTEM (LICENCE #67361)
4. VITROS 5,1 FS CHEMISTRY SYSTEM (REFURBISHED) (LICENCE #67361)

Reason

Ortho Clinical Diagnostics (OCD) has identified a software anomaly that may occur during the installation of an Assay Data Diskette (ADD) using software versions 2.2.1 through 2.8. The anomaly is not caused by the (ADD).
OCD received two customer complaints (outside of Canada) that occurred during the installation of the (ADD). Due to a software coding error for both scenarios, all default settings were restored from the (ADD) instead of retaining the user configured parameters and the operator was not alerted by the system. If this anomaly occurs, the VITROS 5.1 FS System may process samples using the default reporting units from the (ADD) instead of the user modified parameters (i.e. SI vs conventional units). However, numerical results will be correct for the actual units reported on the VITROS System.

Affected products