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Terminated

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

FDA Recall Z-2864-2017 · Posted None

Recalling FirmHologic, Inc
Recall StatusTerminated
Product CodeJQW
Date Initiated2017-06-27
Date Terminated2023-06-30
Product Quantity164 units

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.

Firm Action

Hologic initiated the recall on Tuesday, June 27, 2017. The method of notification with either: A letter will be provided at a face-to-face meeting with a Hologic representative. Customers will be contacted by phone and electronically sent the letters. The letters will be delivered in one of the following ways: A Hologic representative will hand-deliver the recall letter to the laboratory management. Or Customers will be contacted by phone and electronically sent the letters. The letter states the problem and that a software fix is available. Those with who have the problem will have priority repair.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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