Recall Z-0676-2018 ยท LKV Enzyme Immunoassay, Fetal Fibronectin
Hologic, Inc.
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
| Date | Nov 29, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| Action | Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx. |
| Quantity | 165 kits |
| Distribution | United States (US), Guam (GU), Japan (JP) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.