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xTAG® Cystic Fibrosis Mutation Detection Kit
Luminex Molecular Diagnostics, Inc · Model I006C0068 · UDI-DI 00840487100455
NUA
Prescription
10
510(k) clearances
5
Adverse events
2
Recalls
1
Facilities
Description
The xTAG® Cystic Fibrosis Kit 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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