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

Reason: 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.

Code information: Lot Numbers: C33xx C34xx C35xx (xx denotes sublots)

Distribution pattern: 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.