Device recall
Z-1658-2011: Rapid fFN for the TLi IQ system and specimen collection kit in the following…
FDA device recall · Class II · Cytyc Prenatal Products/Hologic Inc.
Key facts
| Recall number (Z-number) | Z-1658-2011 |
|---|---|
| Recall event | 54136 |
| Product | Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 0797 Specimen Collection Kit (8 pack); manufactured by Hologic, Sunnyvale, CA. Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen… |
| Product code | LKV |
| Recalling firm | Cytyc Prenatal Products/Hologic Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 16, 2011 |
| 510(k) numbers | K900225 |
| FEI number | 2024800 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database