Hologic Tomcat Instrument Software Issue May Cause Incorrect Patient Results
Hologic recalls Tomcat laboratory instruments with software anomaly that may cause incorrect patient results. Affected units include specific model numbers listed in the recall notice.
Lower-risk 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.
Contact the company
What happened, in plain English
Hologic is recalling certain Tomcat laboratory instruments due to a software issue that might cause incorrect patient results. This could affect test accuracy and patient care if the instrument is used without correction. Read more at govinfonow.com/recall/73546-hologic-tomcat-instrument-software-issue-may-cause-incorrect-patient-results.
Source Summary by GovInfoNow · govinfonow.com/recall/73546-hologic-tomcat-instrument-software-issue-may-cause-incorrect-patient-results · Updated September 21, 2026 · FDA enforcement record: FDA #Z-2864-2017
Cite this page
“Hologic Tomcat Instrument Software Issue May Cause Incorrect Patient Results.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73546-hologic-tomcat-instrument-software-issue-may-cause-incorrect-patient-results. Based on FDA recall #Z-2864-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2864-2017%22&limit=1).
Why it’s dangerous
The software anomaly causes the pipettor arm to contact the mucous shelf, which could lead to inaccurate patient test results. This issue does not involve physical harm but affects test accuracy.
Who’s affected
Laboratory users with the affected Tomcat instruments may be at risk of incorrect patient results. Healthcare facilities that use these instruments are most impacted.
How to tell if you have this one
Check if your Tomcat instrument has model numbers listed in the recall notice (TC00000050 through TC00000201, etc.). The recall covers specific units identified by these serial numbers.
- Brand
Hologic- Category
Medical device
What to do — step by step
Check Instrument Model
Identify your Tomcat instrument's model number from the list of affected serial numbers provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution. US Nationwide and countries: BE, CA, CH, ES, FR, GB, IE, IT, JP, LU, NL, SE, SK, and TR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2864-2017 (June 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2864-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.