Home › Luminex Molecular Diagnostics, Inc › xTAG® Cystic Fibrosis (CFTR) 39 kit v2
xTAG® Cystic Fibrosis (CFTR) 39 kit v2
Luminex Molecular Diagnostics, Inc · Model I027C0231 · UDI-DI 00840487100141
NUA
Prescription
10
510(k) clearances
5
Adverse events
2
Recalls
1
Facilities
Description
The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-03-31 | Hologic, Inc | Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing. |
| 2016-03-31 | Hologic, Inc | Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing. |
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