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FDAJune 27, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

hologic

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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