Hologic Tomcat Instrument Recalled for Software Anomaly Affecting Sample Processing
Hologic is recalling 164 Tomcat Instruments due to a software anomaly that may cause the pipettor arm to contact the mucous shelf, potentially leading to incorrect patient results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of incorrect patient results without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hologic, Inc. is recalling 164 units of the Tomcat Instrument (REF ASY-07379), an automated laboratory sample processing instrument. The recall is due to a software anomaly that causes the pipettor arm to make physical contact with the mucous shelf. This mechanical interaction could potentially lead to incorrect patient results.
The affected units were distributed worldwide, including the United States and the following countries: Belgium, Canada, Switzerland, Spain, France, United Kingdom, Ireland, Italy, Japan, Luxembourg, Netherlands, Sweden, Slovakia, and Turkey. Specific unit codes are listed in the agency's recall record.
Healthcare facilities and laboratories should stop using the affected Tomcat Instruments and contact Hologic for further instructions on the recall process.
The recalled product
- Product
- Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
- Manufacturer
- Hologic, Inc
- Affected units
- 164
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- TC00000050
- TC00000058
- TC00000059
- TC00000060
- TC00000061
- TC00000062
- TC00000063
- TC00000064
- TC00000065
- TC00000067
- TC00000068
- TC00000069
- TC00000070
- TC00000071
- TC00000072
- TC00000073
- TC00000074
- TC00000075
- TC00000076
- TC00000077
Distribution
Distributed nationwide across the United States.
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