Recall Z-1580-2016— Hologic, Inc

Name: FDA recall Z-1580-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-31

Class II · Terminated

Class II FDA medical device recall by Hologic, Inc, initiated 2016-03-31, terminated 2016-08-09. It names one FDA 510(k) clearance: K063787. Product: 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..

Recalling firm: Hologic, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-03-31
Terminated: 2016-08-09
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K063787 — INPLEX CF MOLECULAR TESTThird Wave Technologies, Inc.·cleared 2008-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.