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FDAMarch 31, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

hologic

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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CF InPlex ASR Card; Catalog Number: 95-0501. — Recall Details · AllClear