Hologic, Inc: Medical Device Recall in 2016 - (Recall #: Z-1579-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

CF InPlex ASR Card; Catalog Number: 95-0501.

Product Classification:

Class II

Date Initiated: March 31, 2016

Date Posted: May 4, 2016

Recall Number: Z-1579-2016

Event ID: 73747

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2580 total

Code Information:

Lot Numbers: U34xx U35xx (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.

Voluntary or Mandated:

Voluntary: Firm initiated