Class II — Hologic, Inc
| Recalling firm | HOLOGIC, INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument. |
| Quantity | 164 units |
| Distribution | Worldwide distribution. US Nationwide and countries: BE, CA, CH, ES, FR, GB, IE, IT, JP, LU, NL, SE, SK, and TR. |
| Initiated | 2017-06-27 |
| Classified | 2017-08-02 |
| Terminated | 2023-06-30 |
| Recall number | Z-2864-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hologic, Inc (Z-2864-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77697/
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