Hologic, Inc recalls Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.

Recall date

June 27, 2017

Source

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

Recall number

Z-2864-2017

FDA classification

Class II

Brand / firm

Hologic, Inc

Sold / distributed

Worldwide distribution. US Nationwide and countries: BE, CA, CH, ES, FR, GB, IE, IT, JP, LU, NL, SE, SK, and TR.

Why it was recalled

A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient 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

Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.