Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
Reported: August 9, 2017 Initiated: June 27, 2017 #Z-2864-2017
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.
Details
- Recalling Firm
- Hologic, Inc
- Units Affected
- 164 units
- Distribution
- Worldwide distribution. US Nationwide and countries: BE, CA, CH, ES, FR, GB, IE, IT, JP, LU, NL, SE, SK, and TR.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.. Recalled by Hologic, Inc. Units affected: 164 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2017. Severity: Moderate. Recall number: Z-2864-2017.
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