FDA-Device2016-05-04Class II
CF InPlex ASR Card; Catalog Number: 95-0501.
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
CF InPlex ASR Card; Catalog Number: 95-0501.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1579-2016Don't want to check this manually?
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