FDA-Device2016-05-04Class II
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Hologic, Inc
Hazard
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.
Sold states
Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.
Affected count
2580 total
Manufactured in
10210 Genetic Center Dr, N/A, San Diego, CA, United States
Products
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1580-2016Don't want to check this manually?
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