Rapid for the TLiIQ — Class II medical device recall Z-0676-2018
Terminated recall by Hologic, Inc., reported 2018-02-28, distributed in GU. Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products we
| Recall number | Z-0676-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2017-11-29 |
| Classified | 2018-02-21 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2018-08-22 |
| Distributed | GU |
| Countries outside the US | JP |
| Quantity | 165 kits |
| Model numbers | 01200 |
Product
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Reason for recall
Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.
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-0676-2018. 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.