Vitros Chemistry Systems (2015-04-07)

Starting date:

April 7, 2015

Posting date:

April 30, 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-53179

• Reason
• Affected products

Recalled Products

A. VITROS 5,1 FS CHEMISTRY (DEVICE LICENCE #66236)
B. VITROS 5,1 FS CHEMISTRY (DEVICE LICENCE #66236, REFURBISHED)
C. VITROS 5,1 FS CHEMISTRY (DEVICE LICENCE #67361)
D. VITROS 5,1 FS CHEMISTRY (DEVICE LICENCE #67361, REFURBISHED)
E. VITROS 5600 INTEGRATED SYSTEM (DEVICE LICENCE #78571)
F. VITROS 5600 INTEGRATED SYSTEM (DEVICE LICENCE #80701)
G. VITROS 4600 CHEMISTRY SYSTEM (DEVICE LICENCE #85176 AND #86236)

Reason

Ortho-Clinical Diagnostics, Inc. (OCD) has confirmed instances where the Vitros system allowed urine samples for assays that required acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed. This has been attributed to a software anomaly. Depending upon the assay, urine samples either need to be acidified, alkalized or require no pretreatment. The anomaly occurs when manually programming urine samples or using a downloaded sample program from a laboratory information system (LIS) and the sample program contains assays requiring sample pretreatment and assays requiring no sample pretreatment. if this anomaly occurs, it is possible for Vitros 5,1, 4600 or 5600 systems to process urine samples without the proper pretreatment, potentially leading to biased patient results.

Affected products