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Rapid fFN®
Hologic, Inc. · Model KIT, RAPID FFN 26 CASSETTE TLIIQ SYSTEM · UDI-DI 25420045501154
LKV
Prescription
0
510(k) clearances
4
Adverse events
7
Recalls
4
Facilities
Description
Rapid fFN® test cassettes for the TLI IQ® system, 26 count.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-29 | Hologic, Inc. | 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 |
| 2017-11-29 | Hologic, Inc. | 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 |
| 2009-12-15 | Cytyc Prenatal Products/Hologic Inc. | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict im |
| 2009-12-15 | Cytyc Prenatal Products/Hologic Inc. | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict im |
| 2009-12-15 | Cytyc Prenatal Products/Hologic Inc. | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict im |
| 2009-12-15 | Cytyc Prenatal Products/Hologic Inc. | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict im |
| 2009-12-15 | Cytyc Prenatal Products/Hologic Inc. | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict im |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.