Hologic, Inc recalls Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.

Recall date

March 31, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1580-2016

FDA classification

Class II

Brand / firm

Hologic, Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.