CLASS II Device recall · Reported 4 May 2016 · FDA Enforcement Report

InPlex CF Molecular Test (IVD) recalled by Hologic

Hologic is recalling Hologic InPlex CF Molecular Test (IVD), distributed in 29 states. The recall was initiated on 31 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: C33xx C34xx C35xx (xx denotes sublots)

Quantity recalled2580 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1580-2016
FDA event ID: 73747
Recalling firm: Hologic, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 31 Mar 2016
FDA classified: 27 Apr 2016
Reported: 4 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

31 Mar 2016	Recall initiated by company
27 Apr 2016	Classified by FDA	+27 days
4 May 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

Where it was distributed

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.

Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maine Michigan Missouri North Carolina

Questions about this recall

Is InPlex CF Molecular Test (IVD) recalled?

Yes. Hologic recalled InPlex CF Molecular Test (IVD) on 31 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1580-2016.

Why was it recalled?

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.

Which lots are affected?

Lot Numbers: C33xx C34xx C35xx (xx denotes sublots)

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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