FDA Device recall Z-0676-2018
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
- FDA Device
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200 by Hologic, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0676-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-29 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hologic |
| Distribution | n/a |
Product
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Reason
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.
Identifiers
| code_info | K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0676-2018%22
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