Recall Z-1579-2016— Hologic, Inc

Name: FDA recall Z-1579-2016
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. FDA's recall record names no specific 510(k) clearance for this event. Product: CF InPlex ASR Card; Catalog Number: 95-0501.. 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

Product description

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

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.