Tomcat Instrument — Class II medical device recall Z-2864-2017
Terminated recall by Hologic, Inc, reported 2017-08-09, distributed nationwide. A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous she
| Recall number | Z-2864-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, San Diego, CA, United States |
| Recall initiated | 2017-06-27 |
| Classified | 2017-08-02 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2023-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 164 units |
| Reason classes | software |
| Model numbers | ASY-07379 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2864-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.