Recall Z-2864-2017— Hologic, Inc
Class II · Terminated
Class II FDA medical device recall by Hologic, Inc, initiated 2017-06-27, terminated 2023-06-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.. Reason: 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..
- Recalling firm
- Hologic, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-27
- Terminated
- 2023-06-30
- Firm location
- San Diego, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.