Leica Biosystems Richmond Inc. recalls CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase fi…

Recall date

May 2, 2016

Source

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

Recall number

Z-2039-2016

FDA classification

Class III

Brand / firm

Leica Biosystems Richmond Inc.

Sold / distributed

Worldwide distribution. US nationwide; Portugal, Spain, Thailand, Italy, China, Romania, Egypt, India, France, Hungary, Mexico, Germany, Norway, Turkey, Pakistan, Malaysia, UK, Luxembourg, Israel, Canada, Switzerland, Taiwan, South Africa, Saudi Arabia, Korea, Singapore and Japan.

Why it was recalled

Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.