VITROS Systems (2016-04-07)

Starting date:

April 7, 2016

Posting date:

April 29, 2016

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-58150

• Reason
• Affected products

Affected Products

A. VITROS 3600 Immunodiagnostics System
B. VITROS 5600 Integrated System
C. VITROS 5600 Integrated System
D. VITROS 3600 Immunodiagnostics System

Reason

Ortho Clinical Diagnostics (Ortho) has initiated this recall due to a VITROS system software timing anomaly that could cause two different sample metering scenarios that may lead to erroneous results.

Scenario 1: the VITROS system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample.

Scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) causing sample b to be contaminated and diluted by sample a.

Affected products