FDA recall Z-2864-2017

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-06-27

Report date

2017-08-09

Termination date

2023-06-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2864-2017