FDA Device recall Z-0677-2018
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
- 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: 01200Q 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-0677-2018 |
| 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: 01200Q
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 | E7058 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0677-2018%22
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