Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Int…

Recall date

April 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1914-2016

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

Why it was recalled

Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.