VITROS 5600 Integrated System…

Date

April 13, 2016

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

Product

VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.

Reason

The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.

Distribution pattern

Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.

Quantity

2,101 Total units (1,043 domestically & 1,058 internationally)

Codes and lots

Product Codes: 6802413, 6802915 (Refurbished) Serial numbers: J56000024 - J56002387

Recall started

Feb. 16, 2016

Device type

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Root cause (FDA)

Process control

What the company told customers

On February 16, 2016, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification notices to their customers via FedEx overnight courier, e-communications and via USPS. Customers are advised that there is no impact to the results generated with an affected system. As a precaution, your Ortho-trained service representative will contact you to schedule an inspection of the wiring within the system at your facility. Following the inspection, reconfiguration of the wiring on your system will be performed if appropriate. Please store a copy of the notification with your user documentation until the wires within your system(s) are inspected. In addition, complete the receipt form to indicate that you have been informed of this anomaly. Please return the form to Joe Falvo via email at confirmationadmin@its.jnj.com or via fax to 1-888-557-3759 or 1-585-453-4110. Customers with questions can contact the Technical Solutions Center at 1-800-421-3311 anytime.

Recall number

Z-1348-2016

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1348-2016. The agency record governs; check it and the company before acting.