FDAFDA · Food and drugs·Recall number Z-1580-2016
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Published May 4, 2016 · Recall initiated: March 31, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hologic, Inc
- Distributor
- 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.
- Lot
- Lot Numbers: C33xx C34xx C35xx (xx denotes sublots)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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