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Hologic, Inc recalls CF InPlex ASR Card; Catalog Number: 95-0501.
Recalled May 4, 2016 · FDA recall Z-1579-2016 · Hologic
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. · FDA Class II
Units
2580 total
Sold at
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.
Description
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.
Product
CF InPlex ASR Card; Catalog Number: 95-0501.
Manufacturer(s)
Hologic, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →